FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 2061157
·
Received March 9, 2011
Report
- Report Number
- 3004209178-2011-01764
- Event Type
- Injury
- Date Received
- March 9, 2011
- Date of Event
- February 8, 2011
- Report Date
- February 24, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE NEUROSTIMULATOR WAS EXPLANTED DUE TO INFECTION. THE CULTURE OF THE PT'S (B)(6) WAS (B)(6) FOR (B)(6). 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 | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Hospitalization| R | IMPLANTED:| EXPLANTED:| LEAD: MODEL 3889, LOT # V567767 |