FDA Adverse Event
Injury
Summary report: N
MEDTRONIC
MDR report key: 1276943
·
Received January 2, 2009
Report
- Report Number
- 1276943
- Event Type
- Injury
- Date Received
- January 2, 2009
- Date of Event
- November 5, 2008
- Report Date
- November 17, 2008
- Manufacturer
- MEDTRONIC
- Product Code
- EZW
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- AR, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PHYSICIAN STATES PLACED IN 2004. STOPPED WORKING A COUPLE OF MONTHS AGO AND INSTRUCTED TO HAVE IT REPLACED. REPLACEMENT OF DEVICE WAS COORDINATED WITH PATIENT SHOULDER SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MEDTRONIC | INTERSTIM | EZW | MEDTRONIC | 3023 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Hospitalization |