FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 2101750
·
Received May 10, 2011
Report
- Report Number
- 3004209178-2011-03386
- Event Type
- Malfunction
- Date Received
- May 10, 2011
- Date of Event
- April 1, 2011
- Report Date
- April 11, 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 THE PATIENT FELL AND WAS UNABLE TO COMMUNICATE WITH THE DEVICE FOLLOWING THE FALL. THE DEVICE WAS UNRESPONSIVE TO THE PHYSICIAN PROGRAMMER, PATIENT PROGRAMMER, AND RECHARGER. THE SYSTEM WAS NOT FUNCTIONING AS THE DEVICE DID NOT HAVE BATTERY POWER AND THE LEAD WAS DAMAGED. THE SYSTEM WAS TO BE REPLACED, BUT A DATE HAD NOT BEEN DETERMINED AT THE TIME OF THE REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
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 | 83 YR | IMPLANTED:| LEAD: MODEL 3093, LOT# V360228| EXPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD096432N |