FDA Adverse Event
Injury
Summary report: N
PULSE-GENERATOR, PACEMAKER, EXTERNAL
MDR report key: 2952640
·
Received February 9, 2013
Report
- Report Number
- 2182208-2013-00202
- Event Type
- Injury
- Date Received
- February 9, 2013
- Date of Event
- December 19, 2012
- Report Date
- December 19, 2012
- Manufacturer
- RICE CREEK MFG
- Product Code
- DTE
- PMA / PMN Number
- K971474
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) SHUT DOWN AUTOMATICALLY WHILE RUNNING. THE EPG WAS RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 57771 | PULSE-GENERATOR, PACEMAKER, EXTERNAL | DTE | RICE CREEK MFG | 5318D4 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening |