FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 3043439
·
Received April 9, 2013
Report
- Report Number
- 3004209178-2013-04913
- Event Type
- Injury
- Date Received
- April 9, 2013
- Report Date
- March 27, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3 889-28, LOT# VA05FFA, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION. THE PATIENT'S INCISION REPORTEDLY OPENED UP AND THE ENTIRE SYSTEM WAS EXPLANTED. IT WAS LATER REPORTED THAT IT WAS UNKNOWN IF A CULTURE WAS DONE. THE LOCATION OF THE INFECTION WAS IN THE POCKET WHERE THE DEVICE WAS PLACED. IT WAS NOTED THAT THE PATIENT IS NOW DOING FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 145943 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |