FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 5231810
·
Received November 17, 2015
Report
- Report Number
- 3004209178-2015-23014
- Event Type
- Injury
- Date Received
- November 17, 2015
- Report Date
- October 28, 2015
- 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
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3093-28, LOT# V181439, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. (B)(4).
Description of Event or Problem · 1
THE CONSUMER REPORTED THAT SHORTLY AFTER HAVING THE DEVICE PUT IN, SHE HAD IT REMOVED BECAUSE SHE WAS CONSTANTLY GETTING SHOCKED BY THE DEVICE AND SHE DID NOT LIKE IT. THE PATIENT WAS INDICATED FOR URINARY DYSFUNCTION/ SACRAL NERVE STIM. NO FURTHER INFORMATION WAS PROVIDED ABOUT THIS EVENT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 760091 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |