FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 2172344
·
Received June 23, 2011
Report
- Report Number
- 3004209178-2011-04750
- Event Type
- Malfunction
- Date Received
- June 23, 2011
- Date of Event
- May 27, 2011
- Report Date
- May 27, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PATIENT WAS UNABLE TO ADJUST STIMULATION BECAUSE HER PROGRAMMING WAS NOT FULLY UPLOADED AFTER SHE VISITED HER HEALTH CARE PROFESSIONAL. WHEN SHE TRIED TO TURN ON HER IMPLANTABLE NEUROSTIMULATOR SHE RECEIVED A SHOCK. A MANUFACTURER'S REPRESENTATIVE MET WITH THE PATIENT AND REPROGRAMMED HER DEVICE. SHE WAS DOING FINE AND WAS RECEIVING EFFECTIVE STIMULATION. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM II | EZW | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 3058 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | EXPLANTED:| IMPLANTED:| LEAD: MODEL 3889, LOT# V711743 |