FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 1924804
·
Received December 7, 2010
Report
- Report Number
- 3004209178-2010-10287
- Event Type
- Injury
- Date Received
- December 7, 2010
- Date of Event
- November 10, 2010
- Report Date
- December 2, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ID, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT HAD CELLULITIS WHERE THE RIGHT LEAD WAS INSERTED. THE SKIN WAS RED, FIRM AND WARM TO THE TOUCH. THE PT WAS GIVEN KEFLEX 500 MG ORALLY THREE TIMES DAILY FOR 7 DAYS. THE EVENT RESOLVED WITHOUT SEQUELAE ON (B)(6) 2010.
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 | 68 YR | Male | Required Intervention | EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3093, LOT# V546412| LEAD: MODEL 3093, LOT# V546412| PROGRAMMER: MODEL 3037, LOT# NJD115309N| LEAD: MODEL 3093, LOT# V546412| PROGRAMMER: MODEL 3037, LOT# NJD115309N| EXPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3093, LOT# V546412| IMPLANTED: |