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Patient 1
IT WAS REPORTED THAT ON (B)(6) 2012 THE PATIENT SUFFERED A WORKPLACE INJURY. THIS INJURY REQUIRED A NECESSARY SURGICAL PROCEDURE ON (B)(6) 2012 PERFORMED BY THE PATIENT'S SURGEON. COMPLICATIONS RESULTED FROM THIS INITIAL SURGERY AND RESULTED IN FURTHER SURGICAL PROCEDURES ON (B)(6) 2012, (B)(6) 2012 AND (B)(6) 2013. ONE OR MORE OF THESE SURGERIES INVOLVED PRODUCTS MANUFACTURED BY MEDTRONIC. THE PATIENT DIAGNOSES INCLUDE BUT ARE NOT LIMITED TO (B)(6), SUFFERED LOSS OF VOICE, OTHER THROAT PROBLEMS AND ONYCHOLYSIS. PER MEDICAL RECORDS, IT WAS REPORTED THAT ON (B)(6) 2012 PATIENT UNDERWENT 360 DEGREE CERVICAL FUSION 2 LEVEL CORPECTOMY IN WHICH RHBMP-2/ACS WAS SUED. (B)(6) 2012: PATIENT WITH ADMITTING DIAGNOSIS OF CORPECTOMY OF C5 TO T1. POST-OP DAY 1 FOLLOW-UP: C6-C7 SPINAL CORD COMPRESSION STATUS POST C7 CORPECTOMY ; HYPERLIPIDEMIA; ACUTE KIDNEY INJURY (B)(6) 2012: PATIENT FOLLOW-UP: SEVERE CERVICAL STENOSIS STATUS POST C5-C6 CORPECTOMY, PAIN IS UNCONTROLLED; HYPERLIPIDEMIA; ACCUTE KIDNEY INJURY. (B)(6) 2012: PATIENT FOLLOW-UP: SEVERE CERVICAL STENOSIS STATUS POST C5-C6 CORPECTOMY; HYPERLIPIDEMIA-RESOLVED; ACCUTE KIDNEY INJURY- RESOLVED. (B)(6) 2012: PATIENT DISCHARGED TO HOME. DISCHARGE DIAGNOSIS INDICATES: SEVERE CERVICAL SPINAL STENOSIS WITH COLD COMPRESSIONS STATUS POST C7 PARTIAL CORPECTOMY, DOING FINE; POST-OP HYPOKALEMIA, RESOLVED; POST-OP HOARSENESS OF VOICE PROBABLY SECONDARY TO VOCAL CORD PARALYSIS (B)(6) 2012 PATIENT UNDERWENT MRI OF THORACIC SPINE WITH CONTRAST. IMPRESSIONS: ABNORMAL CORD SIGNAL AT C1-C2, RIGHT SIDED. UNCERTAIN ETIOLOGY; EXTENSIVE POSTSURGICAL CHANGES C5-T1; MILD APPARENT CHRONIC NARROWING OF THE CANAL AT C7 AND T1; NO FOCAL DISC PROTRUSIONS, ABSCESS, OR OTHER ACUTE PROCESS IS DEMONSTRATED (B)(6) 2012 PATIENT UNDERWENT INCISION AND DRAINAGE POSTERIOR CERVICAL WOULD INFECTION WITH WOUND VAC. PATIENT WAS DISCHARGED HOME. (B)(6) 2013: THE PATIENT PRESENTED WITH POST-OP INFECTION. PATIENT DIAGNOSED WITH ANEMIA. PATIENT RECEIVED DAPTOMYCIN. PATIENT WAS DIS CHARGED TO HOME. (B)(6) 2013: THE PATIENT PRESENTED WITH PRIMARY DIAGNOSIS OF UNSPECIFIED DISORDER OF SKIN AND SUBCUTANEOUS TISSUE. PATIENT DIAGNOSED WITH PICC LINE INFECTION. (B)(6) 2013 PATIENT UNDERWENT FLUOROSCOPY OF CERVICAL SPINE FOR HARDWARE REMOVAL. THE C-ARM WAS PROVIDED FOR FLUOROSCOPIC ASSISTANCE. (B)(6)2013: THE PATIENT UNDERWENT ULTRASONIC RENAL EVALUATION. IMPRESSION: NO ANATOMIC LESION OR OBSTRUCTION IN EITHER KIDNEY; SOMEWHAT THICKENED APPEARING RENAL CORTICES BILATERALLY WHICH MAY REFLECT MEDICAL RENAL DISEASE; INCIDENT NOTE OF SPLENOMEGALY; NO FOCAL ABNORMALITY SEEN AT THE DISTENDED URINARY BLADDER (B)(6) 2013: PATIENT DISCHARGED TO HOME (B)(6) 2013: PATIENT PRESENTED WITH A COMPLAINT OF URINARY OBSTRUCTION AND UTI SYMPTOMS. HAVING DIFFICULTY EMPTYING BLADDER.
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Patient 1
(B)(6). (B)(4). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.
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Patient 1
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Patient 1
IT WAS REPORTED THAT ON: (B)(6) 2013: PATIENT PRESENTED FOR FOLLOW UP WITH MRSA POST OP WOUND INFECTION CERVICAL SPINE WITH HARDWARE IN PLACE. ASSESSMENTS: (B)(6). INFECTION AND INFLAMMATORY REACTION DUE TO NERVOUS SYSTEM DEVICE, IMPLANT, AND GRAFT. RASH AND OTHER NONSPECIFIC SKIN ERUPTION OTHER VOICE DISTURBANCE. ON (B)(6) 2013: PATIENT WAS DIAGNOSED WITH (B)(6) INFECTION AND INFLAMMATORY REACTION DUE TO NERVOUS SYSTEM DEVICE, IMPLANTS, AND GRAFT RASH AND OTHER NONSPECIFIC SKIN ERUPTION OTHER VOICE DISTURBANCE DIARRHEA OF PRESUMED INFECTIOUS ORIGIN. ON (B)(6) 2013: PATIENT WAS DIAGNOSED WITH (B)(6) INFECTION AND INFLAMMATORY REACTION DUE TO NERVOUS SYSTEM DEVICE, IMPLANTS, AND GRAFT RASH AND OTHER NONSPECIFIC SKIN ERUPTION OTHER VOICE DISTURBANCE DIARRHEA. ON (B)(6) 2013: PATIENT WAS DIAGNOSED WITH (B)(6) INFECTION AND INFLAMMATORY REACTION DUE TO NERVOUS SYSTEM DEVICE, IMPLANTS, AND GRAFT RASH AND OTHER NONSPECIFIC SKIN ERUPTION OTHER VOICE DISTURBANCE DIARRHEA. ON (B)(6) 2013: PATIENT WAS DIAGNOSED WITH (B)(6) INFECTION AND INFLAMMATORY REACTION DUE TO NERVOUS SYSTEM DEVICE, IMPLANTS, AND GRAFT RASH AND OTHER NONSPECIFIC SKIN ERUPTION OTHER VOICE DISTURBANCE DIARRHEA. ON (B)(6) 2013: PATIENT WAS DIAGNOSED WITH (B)(6) INFECTION AND INFLAMMATORY REACTION DUE TO NERVOUS SYSTEM DEVICE, IMPLANTS, AND GRAFT RASH AND OTHER NONSPECIFIC SKIN ERUPTION OTHER VOICE DISTURBANCE DIARRHEA. PATIENT WAS DIAGNOSED WITH (B)(6) INFECTION AND INFLAMMATORY REACTION DUE TO NERVOUS SYSTEM DEVICE, IMPLANTS, AND GRAFT RASH AND OTHER NONSPECIFIC SKIN ERUPTION OTHER VOICE DISTURBANCE DIARRHEA. ON (B)(6) 2013: PATIENT WAS DIAGNOSED WITH (B)(6) INFECTION AND INFLAMMATORY REACTION DUE TO NERVOUS SYSTEM DEVICE, IMPLANTS, AND GRAFT RASH AND OTHER NONSPECIFIC SKIN ERUPTION OTHER VOICE DISTURBANCE DIARRHEA. ON (B)(6) 2013: PATIENT WAS DIAGNOSED WITH (B)(6) INFECTION AND INFLAMMATORY REACTION DUE TO NERVOUS SYSTEM DEVICE, IMPLANT, AND GRAFT RASH AND OTHER NONSPECIFIC SKIN ERUPTION OTHER VOICE DISTURBANCE DIARRHEA. . ASSESSMENTS: (B)(6). INFECTION AND INFLAMMATORY REACTION DUE TO NERVOUS SYSTEM DEVICE, IMPLANT, AND GRAFT. RASH AND OTHER NONSPECIFIC SKIN ERUPTION OTHER VOICE DISTURBANCE. ON (B)(6) 2013: PATIENT WAS DIAGNOSED WITH (B)(6) INFECTION AND INFLAMMATORY REACTION DUE TO NERVOUS SYSTEM DEVICE, IMPLANT, AND GRAFT RASH AND OTHER NONSPECIFIC SKIN ERUPTION DIARRHEA. . ASSESSMENTS: (B)(6). INFECTION AND INFLAMMATORY REACTION DUE TO NERVOUS SYSTEM DEVICE, IMPLANT, AND GRAFT. RASH AND OTHER NONSPECIFIC SKIN ERUPTION OTHER VOICE DISTURBANCE. ON (B)(6) 2013: PATIENT WAS DIAGNOSED WITH (B)(6) INFECTION AND INFLAMMATORY REACTION DUE TO NERVOUS SYSTEM DEVICE, IMPLANT, AND GRAFT RASH AND OTHER NONSPECIFIC SKIN ERUPTION URINARY TRACT INFECTION, SITE NOT SPECIFIED UNSPECIFIED CONSTIPATION. . ASSESSMENTS: (B)(6). INFECTION AND INFLAMMATORY REACTION DUE TO NERVOUS SYSTEM DEVICE, IMPLANT, AND GRAFT . RASH AND OTHER NONSPECIFIC SKIN ERUPTION OTHER VOICE DISTURBANCE. ON (B)(6) 2013: PATIENT PRESENTED WITH A COMPLAINT OF URINARY OBSTRUCTION AND UTI SYMPTOMS. HAVING DIFFICULTY EMPTYING BLADDER. PATIENT UNDERWENT GENERAL EXAMINATIONS, WHICH SHOWED POSITIVE RESULTS. PATIENT WAS DIAGNOSED WITH INFECTION AND INFLAMMATORY REACTION DUE TO NERVOUS SYSTEM DEVICE, IMPLANT, AND GRAFT RASH AND OTHER NONSPECIFIC SKIN ERUPTION URINARY TRACT INFECTION, SITE NOT SPECIFIED UNSPECIFIED CONSTIPATION. ASSESSMENTS: (B)(6). INFECTION AND INFLAMMATORY REACTION DUE TO NERVOUS SYSTEM DEVICE, IMPLANT, AND GRAFT. RASH AND OTHER NONSPECIFIC SKIN ERUPTION OTHER VOICE DISTURBANCE . ON (B)(6) 2013:PATIENT WAS DIAGNOSED WITH INFECTION AND INFLAMMATORY REACTION DUE TO NERVOUS SYSTEM DEVICE, IMPLANT, AND GRAFT URINARY TRACT INFECTION, SITE NOT SPECIFIED UNSPECIFIED CONSTIPATION CANDIDIASIS OF UNSPECIFIED SITE. . ASSESSMENTS: (B)(6). INFECTION AND INFLAMMATORY REACTION DUE TO NERVOUS SYSTEM DEVICE, IMPLANT, AND GRAFT. RASH AND OTHER NONSPECIFIC SKIN ERUPTION OTHER VOICE DISTURBANCE .ON (B)(6) 2013: PATIENT WAS DIAGNOSED WITH INFECTION AND INFLAMMATORY REACTION DUE TO NERVOUS SYSTEM DEVICE, IMPLANT, AND GRAFT URINARY TRACT INFECTION, SITE NOT SPECIFIED UNSPECIFIED CONSTIPATION, DERMATOPHYTOSIS OF NAIL. . ASSESSMENTS: (B)(6). INFECTION AND INFLAMMATORY REACTION DUE TO NERVOUS SYSTEM DEVICE, IMPLANT, AND GRAFT . RASH AND OTHER NONSPECIFIC SKIN ERUPTION OTHER VOICE DISTURBANCE. ON (B)(6) 2014: PATIENT PRESENTED FOR FOLLOW-UP.
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Patient 1
IT WAS REPORTED THAT ON : (B)(6) 2012 THE PATIENT PRESENTED TO ESTABLISH CARE FOR CHRONIC PROBLEMS. THE PATIENT COMPLAINED OF HYPERTENSION, DIABETES MELLITUS, NEUROPATHY. ON (B)(6) 2012: THE PATIENT PRESENTED FOR ORTHOPEDIC EVALUATION OF BACK INJURY ON (B)(6) AND X-RAYS IN OFFICE (B)(6). ASSESSMENTS: MULTIPLE CONTUSIONS, OTHER SPECIFIED SITES OF SPRAINS AND STRAINS. ON (B)(6) 2012 THE PATIENT WAS PRESENTED FOR OFFICE VISIT FOR GENERAL FOLLOW UP. ASSESSMENTS: OTHER SPECIFIED SITES OF SPRAINS AND STRAINS. ACTIVE PROBLEM LIST: MULTIPLE CONTUSIONS, OTHER SPECIFIED SITES OF SPRAINS AND STRAINS, LIPOMA OF OTHER SKIN AND SUBCUTANEOUS TISSUE. ON (B)(6) 2012: PER MEDICAL RECORDS OMINENT C6-C7 DISC PROTRUSION THAT IS EXTRUDED CEPHLAD WITH MARKED CENTRAL CANAL STENOSIS AND PARTIAL BILATERAL LATERAL FORAMINAL STENOSIS. ON (B)(6) 2012 THE PATIENT PRESENTED FOR FOLLOW UP OF NECK INJURY AND DIABETES MELLITUS. ON (B)(6) 2012: THE PATIENT PRESENTED WITH DIAGNOSIS OF SPINAL STENOSIS AND UNDERWENT X-RAY OF CERVICAL SPINE. IMPRESSION: ABNORMAL CONFIGURATION THROUGH THE PREVIOUSLY FUSED LEVELS C5-T1. PATIENT UNDERWENT CT OF CERVICAL SPINE WITHOUT CONTRAST. IMPRESSION: ABNORMAL CONFIGURATION THROUGH THE PREVIOUSLY FUSED LEVELS C5-T1. PATIENT PRESENTED FOR FOLLOW-UP WITH CT SCAN WHICH SHOWED COMPLETE DISLODGEMENT OF BOTH PLATES ANTERIORLY WITH LOSS OF BOTH HEIGHT AND ANTERIOR KYPHOSIS. X-RAYS SHOWED PLATE HAD SHIFTED ANTERIORLY WITH THE IMPLANT WITH A KYPHOSIS. PATIENT REPORTED TINGLING AND NUMBNESS IN FINGERS AND SOME INTERSCAPULAR PAIN. ON (B)(6) 2012: THE PATIENT WAS STATUS POST ANTERIOR CERVICAL DISCECTOMY , PARTIAL CORPECTOMY AND INTERBODY FUSION WHICH UNDERWENT DISLODGEMENT. THE PATIENT WAS BACK FOR REPAIR. THE OPERATIVE COURSE WAS COMPLICATED BY VOCAL CORD INJURY. ON (B)(6) 2012, THE PATIENT PRESENTED WITH DIAGNOSIS OF RIGHT TRUE VOCAL CORD PARALYSIS. ON (B)(6) 2012, THE PATIENT PRESENTED WITH DIAGNOSIS OF CORD COMPRESSION , S/P 360ࠃERVICAL FUSION , VOCAL CORD PARALYSIS. ON (B)(6) 2012: PATIENT PRESENTED FOR A FOLLOW-UP FROM SURGERY PLUS TO REMOVE STAPLES. ON (B)(6) 2012: PATIENT PRESENTED FOR MEDS REFILL AND COMPLAINED OF PAIN FROM HIS WOUND ON BACK. ON (B)(6) 2012: POSTSURGICAL CHANGES IN THE LOWER CERVICAL TO UPPER THORACIC SPINE DOWN TO T1; QUESTIONABLE MILD CORD ATROPHY LOWER CERVICAL AND UPPER THORACIC SPINE, NO EPIDURAL ABSCESS OR OTHER ACUTE PROCESS, MILD TO MODERATE MULTILEVEL SPONDYLOSIS. PATIENT WAS ADMITTED TO THE FACILITY WITH CHIEF COMPLAINT OF WOUND DRAINAGE. THE PATIENT HAS DYSPHAGIA THE PATIENT UNDERWENT X-RAY WHICH REVEALED DISPLACED SCREW. THE PATIENT DISCOVERED THE LOOSE SCREW ALMOST 3 WEEKS AFTER HIS INITIAL SURGERY. IMPRESSION: (B)(6) MALE WITH CERVICAL DISK DISEASE, STATUS POST. SURGICAL INTERVENTION#2 WITH HARDWARE INSERTION. THE PATIENT HAS DYSPHAGIA AS WELL AS VOCAL CORD DYSFUNCTION. ON (B)(6) 2012 THE PATIENT PRESENTED WITH CHIEF COMPLAINT OF WOUND DRAINAGE. PRE-OPERATIVE DIAGNOSIS: WOUND INFECTION, STATUS POST CER VICAL FUSION WITH INSTRUMENTATION BOTH ANTERIOR AND POSTERIOR. PROCEDURE PERFORMED: OPENING OF WOUND, WASHOUT, REMOVAL OF FUSION, MAINTENANCE OF HARDWARE USING 1L OF 3% BETADINE AND 3L OF BACITRACIN, PLACEMENT OF DRAINS. ASSESSMENT: PATIENT WITH HYPERTENSION, HYOPE RCHOLESTREROLEMIA UNCONTROLLED DIABETES MELLITUS TYPE 2 CERVICAL SPINE STENOSIS SECONDARY TOP HERNIATED NUCLEUS PULPOSUS UNDERGOING DECOMPRESSIVE SURGERIES PRESENTS WITH A WOUND CELLULITIS STATUS POST CERVICAL SPINE DECOMPRESSION SURGERY. ON (B)(6) 2012 THE PATIENT PRESENTED FOR AN OFFICE VISIT. OPERATIVE DIAGNOSIS: POSTERIOR NECK WOUND/ INFECTION. ON (B)(6) 2012 THE PATIENT UNDERWENT RADIOLOGICAL TEST OF THE CHEST AND COMPLAINTS OF NECK PAIN, (B)(6), AMBULATORY DIFFICULTY. PATIENT UNDERWENT XR OF CHEST. IMPRESSION: RIGHT PICC TIP OVER THE SVC. ON (B)(6) 2012: PATIENT WAS DISCHARGED FROM THE FACILITY. ON (B)(6) 2013: THE PATIENT PRESENTED WITH POST OP INFECTION. ON (B)(6) 2013: PATIENT PRESENTED FOR OFFICE VISIT. ON (B)(6) 2013, THE PATIENT PRESENTED FOR FOLLOW UP VISIT. FOLLOWING OBSERVATIONS WERE MADE DURING HER EXAMINATION: - RECENT WEIGHT CHANGE ; CHRONIC AND FREQUENT COUGH ; BAD BREATH VOICE CHANGE ; SWELLING OF FEET, ANKLES OR HANDS. DIARRHEA; KIDNEY STONES AND SEXUAL DISABILITY. ON (B)(6) 2013, PER THE MEDICAL RECORDS, THE PATIENT UNDERWENT CMP, DRUG SCREENING, SEDIMENTATION RATE RBC. ON (B)(6) 2013: THE PATIENT PRESENTED FOR CHANGE OF WOUND VAC. DRESSING, PICC DRESSING. ON (B)(6) 2013: PATIENT CAME FOR FOLLOW-UP. WOUND STILL SHOWED SOME HARDWARE AND WAS CLOSING SLOWLY. ON (B)(6) 2013: PATIENT WAS ADVISED NOT TO GET THE DRESSING WET. PATIENT WOUND VAC. DRESSING CHANGE. ON (B)(6) 2013 THE PATIENT WAS PRESENTED FOR OFFICE VISIT. ASSESSMENTS: HYPERPOTASSEMIA. ON (B)(6) 2013 THE PATIENT UNDERWENT X RAYS OF THE CERVICAL SPINE. FINDINGS: THE ANTERIOR AND POSTERIOR FUSION AT C5-C6-C7-T1 REMAINS STABLE IN APPEARANCE. THE ANTERIOR PLATE, VERTEBRAL CAGES AND POSTERIOR FIXATION PLATES ALL APPEAR THE SAME AS BEFORE. ALIGNMENT...