FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 1972401
·
Received January 24, 2011
Report
- Report Number
- 3004209178-2011-00566
- Event Type
- Injury
- Date Received
- January 24, 2011
- Date of Event
- August 23, 2010
- Report Date
- January 10, 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
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT HAD NOT HAD STIMULATION IN 4 YEARS. THE DEVICE WAS REMOVED AND REPLACED. THE PT CAME IN FOR POST-OP PROGRAMMING AND WAS DOING VERY WELL.
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 | 66 YR | Required Intervention | EXPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD106684N| IMPLANTED:| LEAD: MODEL 3889, LOT# V012107 |