FDA Adverse Event
Injury
Summary report: N
INTERSTIM II
MDR report key: 3761191
·
Received April 21, 2014
Report
- Report Number
- 3004209178-2014-07552
- Event Type
- Injury
- Date Received
- April 21, 2014
- Report Date
- April 1, 2014
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: PRODUCT ID 3093-28, LOT # V029657, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT HAD A REVISION. IT WAS NOTED THE LEAD AND STIMULATOR WERE MOVED FROM THE LEFT SIDE TO THE RIGHT. IT WAS REPORTED THE REASON FOR REVISION WAS UNKNOWN, BUT MAY HAVE BEEN DUE TO LEAD PROBLEMS AND SHOCKING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 241172 | INTERSTIM II | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3058 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00055 YR | Required Intervention |