FDA Adverse Event
Malfunction
Summary report: N
PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE
MDR report key: 3993983
·
Received August 8, 2014
Report
- Report Number
- 2183613-2014-01058
- Event Type
- Malfunction
- Date Received
- August 8, 2014
- Date of Event
- May 21, 2014
- Report Date
- May 21, 2014
- Manufacturer
- MEDTRONIC MILACA, INC.
- Product Code
- LWP
- PMA / PMN Number
- P820003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, 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 THERE WERE MISSING PIXELS ON THE LOWER DISPLAY OF THE EXTERNAL PULSE GENERATOR (EPG). THE EPG WILL BE RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 469961 | PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE | LWP | MEDTRONIC MILACA, INC. | 5388 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |