FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 2171020
·
Received June 30, 2011
Report
- Report Number
- 3004209178-2011-04961
- Event Type
- Malfunction
- Date Received
- June 30, 2011
- Date of Event
- June 3, 2011
- Report Date
- June 3, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- EZW
- PMA / PMN Number
- P970004
- 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 NEUROSTIMULATOR WOULD NOT LOCK DOWN TO SECURE A LEAD. THE LEAD WAS SHOWING HIGH IMPEDANCES ON SEVERAL ELECTRODE COMBINATIONS. THE LEAD AND NEUROSTIMULATOR WERE REPLACED. THERE WAS NO INJURY TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERSTIM II | EZW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 3058 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Required Intervention | IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3093, LOT# V718229| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3093, LOT# V718229| IMPLANTABLE NEURO STIMULATOR: MODEL 3058,| LOT# NJY170606H| EXPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD129826N |