FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 2220215
·
Received August 16, 2011
Report
- Report Number
- 3004209178-2011-06429
- Event Type
- Injury
- Date Received
- August 16, 2011
- Date of Event
- July 1, 2011
- Report Date
- July 25, 2011
- 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
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT HAD REVISION SURGERY TO MOVE HER IMPLANTABLE NEUROSTIMULATOR TO THE OTHER SIDE BECAUSE HER DEVICE WAS NOT WORKING. ADD'L INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
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 | 57 YR | Required Intervention | EXPLANTED:| LEAD: MODEL 3093, LOT# V535583| IMPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD113474N |