FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 2101732
·
Received May 10, 2011
Report
- Report Number
- 3004209178-2011-03376
- Event Type
- Malfunction
- Date Received
- May 10, 2011
- Date of Event
- April 1, 2011
- Report Date
- April 14, 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
- KS, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PATIENT EXPERIENCED A INTERMITTENT LOSS OF THERAPEUTIC EFFECT AND NO STIMULATION SENSATION WHICH BEGAN ABOUT 2 WEEKS AGO. THERE WAS NO ACCIDENT OR INCIDENT RELATED THIS EVENT. IT WAS NOTED THAT THE PATIENT NEVER HAD "GREAT" BENEFIT BUT WAS GETTING SOME THERAPY BENEFIT. IMPEDANCE MEASUREMENTS SHOWED >4000 OHMS ON ALL ELECTRODE COMBINATIONS WITH #0 AND 1. THE PATIENT HAD BEEN PROGRAMMED WITH ELECTRODE #3 (+) AND 1 (-) IN THE PAST. THE HEALTHCARE PROFESSIONAL ATTEMPTED REPROGRAMMING BUT PATIENT DID NOT HAVE ANY STIMULATION SENSATION. X-RAYS THAT WERE TAKEN WERE REPORTED AS UNREMARKABLE. ADDITIONAL INFORMATION WAS REQUESTED.
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 | 55 YR | PROGRAMMER: MODEL 3037, LOT# NJD092437N| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3889, LOT# V345262 |