FDA Adverse Event
Injury
Summary report: N
EXOGEN
MDR report key: 1022511
·
Received March 31, 2008
Report
- Report Number
- 1020279-2008-00104
- Event Type
- Injury
- Date Received
- March 31, 2008
- Date of Event
- March 18, 2008
- Report Date
- March 18, 2008
- Manufacturer
- SMITH & NEPHEW, INC., ORTHOPAEDIC DIV.
- Product Code
- LOF
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED BY THE PATIENT THT HIS PACEMAKER STOPPED WORKING DURING USAGE OF THE DEVICE. AS A RESULT, THE PATIENT HAD TO HAVE ANOTHER PACEMAKER INSTALLED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXOGEN | BONE GROWTH STIMULATOR | LOF | SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR |