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 6595166
- MDR report key
- 6595166
- Report number
- 3007566237-2017-02052
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-05-11
- Date received
- 2017-05-26
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- 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 | ACTIVA PC+S | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MEDTRONIC PUERTO RICO OPERATIONS CO. | MFR | 37604 | 37604 | * | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-05-26 | 0 |
Event Narratives#
D
Patient 1
INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER (HCP) OF A CLINICAL STUDY VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING AN UNSPECIFIED AMOUNT PATIENTS WHO WERE IMPLANTED WITH A NEUROSTIMULATOR FOR OBSESSIVE COMPULSIVE DISORDER (OCD). IT WAS REPORTED THAT THE BATTERIES WERE DEPLETING FASTER THAN ANTICIPATED. EACH OF THE PATIENT'S BATTERIES WILL NEED REPLACING WITHIN THE TRIAL PERIOD OF 2 YEARS, POST-SURGERY. IT WAS UNKNOWN WHEN THE EVENT(S) BEGAN OCCURRING. NO SYMPTOMS WERE REPORTED.
N
Patient 1
UPON REVIEW OF THE ADDITIONAL INFORMATION RECEIVED, IT WAS DETERMINED THAT (B)(4) NO LONGER APPLIES. 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). IT WAS REPORTED THAT USING BATTERY LIFE ESTIMATOR WITH A NOMINAL SET OF PARAMETERS TYPICALLY USED WITH THESE PATIENTS, THE DURATION OF THE BATTERY WAS ESTIMATED TO BE ABOUT 2 YEARS. SINCE THESE BATTERIES REQUIRE AN ADDITIONAL DRAIN FOR THE SENSING FEATURE AND THIS FEATURE ONLY BEING USED DURING THE CLINIC VISITS, THE SENSING FEATURE WOULD CONTRIBUTE TO A 10% HIT TO THE BATTERY. IT WAS THEN STATED THAT GIVEN THIS INFORMATION, THE BATTERY LIFE THAT WAS REPORTED DID NOT SEEM TO BE WHOLLY UNEXPECTED (WITHIN REASON GIVEN THE USE CASE FOR THESE PATIENTS). IT WAS ALSO REPORTED THAT NO ACTIONS WERE TAKEN AT THIS TIME; NO DEVICES WERE EXPLANTED. HOWEVER, ONE PATIENT'S DEVICE REACHED END OF SERVICE (EOS) AFTER PREVIOUSLY REACHING ELECTIVE REPLACEMENT INDICATOR (ERI) ON (B)(6) 2017, AND WILL LIKELY BE EXPLANTED SOMETIME SOON. IT WAS NOTED THAT THE BATTERY DRAIN WAS WITHIN REASONABLE EXPECTATION. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.
N
Patient 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
D
Patient 1
NO NEW INFORMATION WAS RECEIVED.