N
Patient 1
(B)(6). 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 6685625
- MDR report key
- 6685625
- Report number
- 3004209178-2017-14157
- Event key
- 0
- Event type
- 3
- Date of event
- 2017-06-07
- Date received
- 2017-07-05
- 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 | MEDTRONIC PUERTO RICO OPERATIONS CO. | MFR | 37604 | 37604 | N | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2017-07-05 | 0 | 1. R |
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 OR OBSESSIVE COMPULSIVE DISORDER (OCD). IT WAS REPORTED THAT THE ACTIVA PC+S BATTERY LIFE DID NOT LAST AS LONG AS ANTICIPATED SO THE DEVICE WAS SURGICALLY REPLACED WITH AN ACTIVA PC. THE DIAGNOSTIC METHODS INCLUDED MONITORING THE BATTERY STATUS. IT WAS ALSO STATED THAT THE EVENT WAS RESOLVED AT THE TIME OF THIS REPORT. THERE WAS NO KNOWN IMPACT OR CONSEQUENCE TO THE PATIENT. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.
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 RECEIVED REPORTED THE CAUSE OF THE BATTERY NOT LASTING AS LONG AS ANTICIPATED WAS NOT KNOWN.
N
Patient 1
NO SIGNIFICANT ANOMALIES WERE FOUND WITH THE IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY. THE DEVICE REACHED NORMAL END OF LIFE AND THE TELEMETRY AND OUTPUT WERE OKAY. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.