FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 1972397
·
Received January 20, 2011
Report
- Report Number
- 3004209178-2011-00495
- Event Type
- Injury
- Date Received
- January 20, 2011
- Report Date
- January 7, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT'S DEVICE WAS EXPLANTED DUE TO AN INFECTION IN THE POCKET. 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 | Required Intervention | LEAD: MODEL 3093, LOT# V380842| IMPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD099434N| EXPLANTED:| EXPLANTED:| IMPLANTABLE NEURO STIMULATOR:| MODEL 3058, LOT# NJY142339H| IMPLANTED:| LEAD: MODEL 3093, LOT# V380842| IMPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD099418N| EXPLANTED: |