FDA Adverse Event
Malfunction
Summary report: N
INTERSTIM II
MDR report key: 1934195
·
Received December 8, 2010
Report
- Report Number
- 3004209178-2010-10317
- Event Type
- Malfunction
- Date Received
- December 8, 2010
- Date of Event
- November 27, 2010
- Report Date
- December 2, 2010
- 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 Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT AFTER A FALL, THE PT LOST STIMULATION AND THERAPEUTIC EFFECT. THE PT FELL STEPPING INTO A BOAT AND LANDED ON HER OPPOSITE HIP. THE PT ADJUSTED STIMULATION WITH NO CHANGE IN STIMULATION. THE PT PLANNED TO CHANGE THE AMPLITUDE TO SEE IF THAT AFFECTED STIMULATION. THE PT WAS REDIRECTED TO HER PHYSICIAN. ADD'L INFO WAS REQUESTED.
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 | 48 YR | LEAD: MODEL 3889, LOT# V299391| PROGRAMMER: MODEL 3037, LOT# NJD090635N| EXPLANTED:| IMPLANTED: |