FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 2061974
·
Received April 6, 2011
Report
- Report Number
- 3004209178-2011-02641
- Event Type
- Malfunction
- Date Received
- April 6, 2011
- Date of Event
- January 1, 2010
- Report Date
- March 28, 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
- NOT APPLICABLE
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A LOSS OF THERAPEUTIC EFFECT WITH LOSS OF BLADDER AND BOWEL CONTROL. THE PATIENT HAD A KNEE REPLACEMENT IN (B)(6) 2010 AND NOTICED SOME CHANGES IN THERAPY AFTERWARD. THE OTHER KNEE WAS REPLACED ON (B)(6) 2011 AND SYMPTOMS HAD INCREASED SINCE THEN. THE PATIENT BROUGHT THEIR PATIENT MANUAL AND HAD "OTHER PAPERS" THAT THEY GAVE TO THE ANESTHESIOLOGIST PRIOR TO SURGERY. THE PATIENT HAD "FECAL INCONTINENCE" FOR 3 WEEKS. THE PATIENT HAD AN APPOINTMENT WITH THEIR HCP SCHEDULED FOR (B)(6) 2011. 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 | 68 YR | Female | EXPLANTED:| IMPLANTED:| LEAD: MODEL 3093, LOT# V192503| PROGRAMMER: MODEL 3037, LOT# NJD082576N| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3093, LOT# V192503| PROGRAMMER: MODEL 3037, LOT# NJD082576N |