FDA Adverse Event
Injury
Summary report: N
INTERSTIM
MDR report key: 1822623
·
Received August 27, 2010
Report
- Report Number
- 3004209178-2010-06524
- Event Type
- Injury
- Date Received
- August 27, 2010
- Date of Event
- January 1, 2010
- Report Date
- July 29, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF STIMULATION. THERE WAS A REVISION/REPLACEMENT OF THE LEAD. IT WAS NOTED THAT THE NEUROSTIMULATOR WAS TWISTED SO MANY TIMES THAT THE LEAD HAD SPLIT IN HALF. SEE MANUFACTURER REPORT # 3004209178201006521 FOR SUBSEQUENT ISSUE OF HIGH AND LOW IMPEDANCES, NO STIMULATION SENSATION, AND LACK OF EFFECT ON DIFFERENT NEUROSTIMULATOR SYSTEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM | EZW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 3023 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Required Intervention | IMPLANTED,| PROGRAMMER: MODEL 3031A, LOT# NGM009483P| LEAD: MODEL 3889, LOT# J0503510V| EXTENSION: MODEL 3095, LOT# NAH017496V| IMPLANTED:| LEAD, MODEL 3889, LOT# J0503510V| EXPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED: |