FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 2093010
·
Received May 5, 2011
Report
- Report Number
- 3004209178-2011-03263
- Event Type
- Malfunction
- Date Received
- May 5, 2011
- Report Date
- April 8, 2011
- 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
- GA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS STATED THAT THE DEVICES WERE NOT WORKING. THE PT HAD TWO INTERSTIM SYSTEMS. HE FELT THEY WERE SHOCKING HIM EVEN WHEN TURNED OFF AND THEY WERE CAUSING NUMBNESS IN THE LOWER BACK ALONG WITH BRIEF AND INTENSE PAIN. THE PT WANTED THE DEVICES REMOVED. FURTHER INFO IS BEING REQUESTED FROM THE HCP. SEE ALSO MFR REPORT 3007566237-2011-03264.
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 | LOT # UNK| LEAD: MODEL 3889, LOT # V065682| PROGRAMMER: MODEL 3037, LOT # NJD058892N| IMPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL IPG URO| IMPLANTED:| EXPLANTED:| EXPLANTED: |