N
Patient 1
A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MAUDE MDR 7233640
- MDR report key
- 7233640
- Report number
- 3007566237-2018-00313
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-12-25
- Date received
- 2018-02-01
- 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 | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN IMPLANTABLE NEUROSTIMULATOR | MEDTRONIC PUERTO RICO OPERATIONS CO. | MFR | 37604 | 37604 | * | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-02-01 | 0 | 1. H; 2. L; 3. O |
Event Narratives#
D
Patient 1
INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER (HCP) OF A CLINICAL STUDY VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR OBSESSIVE COMPULSIVE DISORDER (OCD). THE PATIENT CONTACTED PHYSICIANS ON (B)(6) 2017 TO REPORT A FOUR DAY HISTORY OF SEVERE SUICIDAL IDEATION THAN USUAL BASELINE. IT WAS NOTED A PHYSICIAN HAD ADJUSTED THE DEEP BRAIN STIMULATION (DBS) ON (B)(6) 2017 TO A STIMULATION AMPLITUDE OF 5.3 V BILATERALLY AND BELIEVED THE SUICIDAL IDEATIONS DID NOT SEEM LIKELY RELATED TO THE DEVICE GIVEN THE LACK OF TEMPORAL ASSOCIATION WITH ADJUSTMENT TO STIMULATION AND THE CURRENT PRESENTATION TO THE PATIENT'S LONGITUDINAL HISTORY OF CHRONIC DEPRESSION. THERE WERE NO SIGNIFICANT STRESSORS OR CHANGES IN PSYCHOTROPIC MEDICATION NOR NEUROVEGETATIVE DISTURBANCE, AND THE PATIENT HAD NO ACTIVE INTENT TO COMMIT SUICIDE, BUT WAS STRUGGLING TO COPE. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2018 FOR OBSERVATION AND MONITORING. THE EVENT OUTCOME WAS CONSIDERED ONGOING. NO FURTHER COMPLICATIONS WERE REPORTED.
N
Patient 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
N
Patient 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
D
Patient 1
ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER (HCP) OF A CLINICAL STUDY VIA A MANUFACTURER REPRESENTATIVE (REP). INTERVENTIONS RELATED TO THE ISSUE INCLUDE ATTENDANCE OF INPATIENT THERAPY PROGRAMS. DIAGNOSTICS WERE NOT SPECIFIED BY THE HOSPITAL THAT ADMITTED THE PATIENT. IT WAS NOTED THE PATIENT HAD MONTREAL COGNITIVE ASSESSMENT (MOCA) AND YALE-BROWN OBSESSIVE COMPULSIVE SCALE (YBOCS) SCORES OF (B)(6) AND (B)(6), RESPECTIVELY, DURING A STUDY VISIT ON (B)(6) 2018. IT WAS ALSO NOTED THE PATIENT HAS A HISTORY OF SEVER TREATMENT RESISTANT OCD, MODERATE DEPRESSIVE DISORDER, MIX CLUSTER OF PERSONALITY TRAITS AND LONG-TERM UNEMPLOYMENT AND FAILED JOB INTERVIEWS. ACUTE RISKS WERE DESCRIBED AS LOW AND THE PATIENT WAS DISCHARGED WITH NO CHANGE IN TREATMENT. THE PATIENT READMITTED THEMSELVES TO ANOTHER HOSPITAL FOLLOWING DISCHARGE AND CURRENTLY CONTINUES AS AN INPATIENT. NO FURTHER COMPLICATIONS WERE REPORTED.