FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 4863489
·
Received June 23, 2015
Report
- Report Number
- 3004209178-2015-12074
- Event Type
- Injury
- Date Received
- June 23, 2015
- Report Date
- June 18, 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
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3093-28, LOT# V082175, IMPLANTED: 2008-(B)(6), PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) WAS NO LONGER EFFECTIVE FOR THEM. THEY STATED THAT THE DEVICE STILL FUNCTIONS BUT IS NOT EFFECTIVE. THE PATIENT ALSO STATED THAT THEIR BLADDER WAS ¿KAPUT¿.IT WAS LATER REPORTED THAT THE PATIENT WAS HAVING HER DEVICE REMOVED AS IT WAS NOT HELPING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 405494 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00053 YR | Required Intervention |