FDA Adverse Event
Injury
Summary report: N
INTERSTIM
MDR report key: 3642547
·
Received February 24, 2014
Report
- Report Number
- 3004209178-2014-03456
- Event Type
- Injury
- Date Received
- February 24, 2014
- Report Date
- January 27, 2014
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 3889-28, LOT# V003775, IMPLANTED: 2006 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3095-10, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6); PRODUCT TYPE EXTENSION. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD NOT FELT STIMULATION SINCE LAST WEEK AND HAD BEEN RUNNING TO THE BATHROOM A LOT SINCE LAST WEEK. NO FALLS OR TRAUMA WERE REPORTED. IT WAS REPORTED THE PATIENT HAD NO CONCERNS WITH THEIR DEVICE. IT WAS NOTED, THE PATIENT RECEIVED ASSISTANCE FROM THEIR DOCTOR ON (B)(6). IT WAS REPORTED, THE PATIENT HAD A SURGERY SCHEDULED FOR 2014 (B)(6) WITH THEIR DOCTOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 111967 | INTERSTIM | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3023 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00067 YR | Required Intervention |