FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 4018237
·
Received August 18, 2014
Report
- Report Number
- 3004209178-2014-15482
- Event Type
- Injury
- Date Received
- August 18, 2014
- Report Date
- August 5, 2014
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- EZW
- PMA / PMN Number
- P080025
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3093-28, LOT# V940070, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT HAD A DEVICE IMPLANTED FOR TWO YEARS AND IT HELPED A LOT INITIALLY, BUT THE PATIENT JUST HAD IT REMOVED. IT WAS LATER REPORTED THAT THE DEVICE WAS REMOVED BECAUSE THE PATIENT FELT IT WAS NO LONGER EFFECTIVE. NO TROUBLESHOOTING, INTERVENTIONS, OR OTHER ACTIONS WERE TAKEN. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 494887 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |