FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 1940358
·
Received December 20, 2010
Report
- Report Number
- 3004209178-2010-10606
- Event Type
- Injury
- Date Received
- December 20, 2010
- Date of Event
- December 14, 2010
- Report Date
- December 14, 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 Location
- PA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT NOTICED A "BUMP" ON HER HIP AT THE SITE OF THE NEUROSTIMULATOR THIS MORNING AND IT LOOKED LIKE "IT WAS PUSHING OUT THROUGH MY SKIN." SHE ALSO EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AND WAS NOT ABLE TO ADJUST HER STIMULATION. ADDITIONAL 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 | 59 YR | Required Intervention | EXPLANTED:| LEAD: MODEL 3093, LOT #: V314891| PROGRAMMER: MODEL 3037, LOT #: NJD092149N| IMPLANTED: |