FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 3586861
·
Received January 22, 2014
Report
- Report Number
- 3004209178-2014-00929
- Event Type
- Injury
- Date Received
- January 22, 2014
- Report Date
- December 30, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 3037, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3 889-28, LOT# V192542, IMPLANTED: 2009 (B)(6); PRODUCT TYPE LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS RECENTLY SICK, HAD BLADDER INFECTIONS, AND JUST GOT OUT OF THE HOSPITAL TWO WEEKS PRIOR TO THE REPORT. IT WAS NOTED THAT DUE TO THE BLADDER INFECTION SHE WAS DESPERATE TO ADJUST THE STIMULATION FOR SYMPTOM RELIEF. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 51972 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00081 YR | Hospitalization| R |