FDA Adverse Event
Injury
Summary report: N
PULSE-GENERATOR, PACEMAKER, EXTERNAL
MDR report key: 2952385
·
Received February 9, 2013
Report
- Report Number
- 2183613-2013-00113
- Event Type
- Injury
- Date Received
- February 9, 2013
- Date of Event
- December 10, 2012
- Report Date
- December 10, 2012
- Manufacturer
- MEDTRONIC MILACA, INC.
- Product Code
- DTE
- PMA / PMN Number
- P820003/S72
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LIQUID CRYSTAL DISPLAY (LCD) ON THE EXTERNAL PULSE GENERATOR (EPG) HAS DARK SPOTS. THEREFORE, 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 |
|---|---|---|---|---|---|---|---|
| 57535 | PULSE-GENERATOR, PACEMAKER, EXTERNAL | DTE | MEDTRONIC MILACA, INC. | 5388 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |