FDA Adverse Event
Malfunction
Summary report: N
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
MDR report key: 2952693
·
Received February 9, 2013
Report
- Report Number
- 2183613-2013-00140
- Event Type
- Malfunction
- Date Received
- February 9, 2013
- Date of Event
- November 28, 2012
- Report Date
- November 28, 2012
- Manufacturer
- MEDTRONIC MILACA, INC.
- Product Code
- LWP
- PMA / PMN Number
- P820003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
FURTHER REVIEW PROMPTED A CHANGE IN THE DEVICE ANALYSIS RESULTS. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4) 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) WOULD NOT POWER ON. THE ENGINEER FOUND BATTERY DEPLETION. THERE WAS NO PATIENT INVOLVEMENT INDICATED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) WOULD NOT POWER ON. THE ENGINEER FOUND BATTERY DEPLETION. THERE WAS NO PATIENT INVOLVEMENT INDICATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 56222 | PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE | LWP | MEDTRONIC MILACA, INC. | 5348 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |