FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM
MDR report key: 3241276
·
Received July 22, 2013
Report
- Report Number
- 3007566237-2013-02431
- Event Type
- Malfunction
- Date Received
- July 22, 2013
- Date of Event
- June 26, 2013
- Report Date
- June 27, 2013
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT EXPERIENCED "STIMULATION IN THE WRONG LOCATION." IT WAS STATED THE PATIENT FELT "STIMULATION DOWN HER LEGS" STARTING THE NIGHT PRIOR TO REPORT. THE PATIENT NOTED HER STIMULATION WAS UP TO 10 AND "WAS COMFORTABLE." IT WAS STATED THE PATIENT WAS SCHEDULED TO SEE HER HEALTH CARE PROVIDER (HCP) THE DAY AFTER REPORT. THE PATIENT WAS REDIRECTED TO HER HCP. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 340289 | INTERSTIM | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC NEUROMODULATION | 3625 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |