FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM
MDR report key: 3242359
·
Received July 23, 2013
Report
- Report Number
- 3007566237-2013-02442
- Event Type
- Malfunction
- Date Received
- July 23, 2013
- Report Date
- June 26, 2013
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 388928, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS NORMAL BATTERY DEPLETION. WHILE THE DOCTOR WAS CHANGING THE BATTERY, HE CLEANED THE ELECTRODE AND THE LEAD BROKE. THERE WERE NO PATIENT SYMPTOMS/INJURIES RELATED TO THIS EVENT. PATIENT OUTCOME WAS NOTED AS ALIVE - NO INJURY/NO ADVERSE EVENT. THE LEAD WAS FUNCTIONING PROPERLY BEFORE THE REPLACEMENT. IT WAS NOTED THAT THE INS WAS FINISHED AND WORKED PROPERLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 343969 | INTERSTIM | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC NEUROMODULATION | NEU_INS_STIMULATOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00063 YR |