FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 3230041
·
Received July 16, 2013
Report
- Report Number
- 3004209178-2013-11858
- Event Type
- Injury
- Date Received
- July 16, 2013
- Date of Event
- August 16, 2012
- Report Date
- June 24, 2013
- 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
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID: 3889-28, LOT# V074430, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD HER STIMULATOR CHANGED IN (B)(6) 2012 AS SOMETHING HAD BECOME LOOSE INSIDE. ADDITIONAL INFORMATION WAS REQUESTED, IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 328350 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00069 YR | Required Intervention |