N
Patient 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MAUDE MDR 9908110
- MDR report key
- 9908110
- Report number
- 3004209178-2020-06476
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-03-23
- Date received
- 2020-03-31
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 3
- 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 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | EZW | 3058 | 3058 | * | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-31 | 0 |
Event Narratives#
D
Patient 1
INFORMATION WAS RECEIVED FROM A PATIENT REGARDING THEIR IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR. PATIENT SAW POWER ON RESET, POR, ON THE PATIENT PROGRAMMER. PATIENT STATES SHE CHANGED BATTERIES PRIOR TO CALLING. PATIENT STATED STIMULATION HAS BEEN OFF SINCE SHE HAD A KNEE REPLACEMENT A YEAR AGO. PATIENT ALSO STATED SHE ALSO HAD X-RAYS ON HER BACK FOR PAIN. NO FURTHER COMPLICATIONS WERE REPORTED