MAUDE MDR 9685118

MDR report key
9685118
Report number
6000030-2020-00011
Event key
0
Event type
3
Date of event
2006-11-01
Date received
2020-02-09
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
LISA WOODWARD CLARK
Address
7000 CENTRAL AVENUE NE RCW215 MINNEAPOLIS MN 55432 US
Phone
763-763-7635
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1IMPLANTABLE NEUROSTIMULATORRICE CREEK MFGOLMNEU_INS_STIMULATORNEU_INS_STIMULATOR* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-0901. H; 2. O; 3. R

Event Narratives#

N

Patient 1

BAGATTI, D., MESSINA, G. CYTOTOXIC LESION IN THE SPLENIUM OF CORPUS CALLOSUM ASSOCIATED WITH INTRACRANIAL INFECTION AFTER DEEP BRAIN STIMULATION. WORLD NEUROSURGERY. 2019. DOI: 10.1016/J.WNEU.2019.12.114. DATE OF EVENT: YEAR IS KNOWN, BUT MONTH AND DAY ARE NOT CONFIRMED. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. IMPLANT DATE: MONTH AND YEAR ARE KNOWN, BUT DAY IS NOT CONFIRMED. SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN, IMPLANTED: (B)(6) 2006, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

D

Patient 1

SUMMARY: CYTOTOXIC LESIONS OF THE CORPUS CALLOSUM (CLOCCS) ARE PRESENT IN A WIDE RANGE OF CLINICAL CONDITIONS. THE TERM ?CLOCCS? REFLECTS CURRENT UNDERSTANDING OF THE UNDERLYING PATHOPHYSIOLOGY OF THESE LESIONS AND DOES NOT NECESSARILY IMPLY THAT THEY ARE CONFINED TO THE SPLENIUM (SCC). SINCE THE SYMPTOMS ARE VARIABLE AND NON-SPECIFIC, THE CLINICAL DIAGNOSIS CAN BE DIFFICULT. BRAIN MRI IS OF PIVOTAL VALUE IN THE INVESTIGATION. WE REPORT THE CASE OF A PATIENT SUFFERING FROM OBSESSIVE-COMPULSIVE DISORDER (OCD) WHO UNDERWENT BILATERAL DEEP BRAIN STIMULATION (DBS) OF THE NUCLEUS ACCUMBENS (NACC) AND DEVELOPED INFECTION ALONG THE SURGICAL PATH OF BOTH ELECTRODES ASSOCIATED WITH CYTOTOXIC LESION IN THE SCC. REPORTED EVENT: A 33 YEAR OLD MALE PATIENT IMPLANTED WITH BILATERAL DEEP BRAIN STIMULATION (DBS) FOR CHRONIC REFRACTORY OBSESSIVE COMPULSIVE DISORDER (OCD) EXPERIENCED CYTOTOXIC LESIONS OF THE CORPUS CALLOSUM FOLLOWING DBS IMPLANT INFECTION. THE PATIENT RECEIVED 1 G OF IV-CEFAZOLIN SODIUM PRIOR TO SKIN INCISION AND 240 MG OF IV-GENTAMICIN POSTOPERATIVELY. THE PATIENT PRESENTED SWELLING, REDNESS, AND HEAT OVER THE SURGICAL SITE APPROXIMATELY 7-10 DAYS AFTER DISCHARGE POST DBS IMPLANT. NEUROLOGICAL EXAMINATION SHOWED EXPRESSIVE APHASIA, PERIPHERAL DEFICIT OF THE RIGHT FACIAL NERVE, AND MODERATE PARESIS OF THE RIGHT UPPER LIMB. BRAIN-CT SHOWED BILATERAL EDEMA WITH FLATTENING OF ADJACENT CORTICAL SULCI ALONG THE SURGICAL PATH OF THE LEADS. BRAIN-MRI DEMONSTRATED A SMALL ISOLATED LESION IN THE SPLENIUM OF CORPUS CALLOSUM (SCC) THAT APPEARED AS A HYPOINTENSE SIGNAL ON T1- AND HYPERINTENSE SIGNAL ON T2-, FLAIR-, AND DWI-SEQUENCES, WITHOUT ENHANCEMENT AFTER CONTRAST ADMINISTRATION. C-REACTIVE PROTEIN (CRP) WAS 11 MG/L AND WHITE CELLS COUNT (WBC) WAS 11 ,000/MM3. WOUND CULTURE GREW STAPHYLOCOCCUS AUREUS AND BLOOD CULTURES WERE NEGATIVE. AN 8-DAY EMPIRIC THERAPY WITH 1000 MG/DAY OF ORAL CLARITHROMYCIN LED TO RAPID IMPROVEMENT OF THE CLINICO-RADIOLOGICAL PICTURE AND REDUCTION OF CRP (0.4) AND WBC (7000 M3). CSF CULTURES WERE NOT PERFORMED. AFTER A SHORT HOSPITALIZATION, THE STABLE PATIENT WAS DISCHARGED ON ORAL CLARITHROMYCIN FOR 7 DAYS. ONE MONTH FOLLOW-UP MRI SHOWED NEARLY COMPLETE REGRESSION OF THE PREVIOUSLY MENTIONED SIGNAL ALTERATION. NO DEVICE INFORMATION COULD BE IDENTIFIED IN THE ARTICLE. SEE ATTACHED LITERATURE ARTICLE.