FDA Adverse Event
Malfunction
Summary report: N
MEDTRONIC, INC.
MDR report key: 7414741
·
Received April 10, 2018
Report
- Report Number
- 3004593495-2018-00197
- Event Type
- Malfunction
- Date Received
- April 10, 2018
- Date of Event
- February 19, 2018
- Report Date
- April 10, 2018
- Manufacturer
- PLEXUS MANUFACTURING SDN. BHD
- Product Code
- DTE
- UDI-DI
- 00643169508767
- PMA / PMN Number
- K150246
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) SHUT OFF IMMEDIATELY AFTER BEING POWERED ON. IT WAS NOTED THAT THE FACILITY'S BIOMEDICAL ENGINEERING DEPARTMENT WAS UNABLE TO REPLICATE THE BEHAVIOR. THE EPG REMAINS IN USE. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 258234 | MEDTRONIC, INC. | PULSE-GENERATOR, PACEMAKER, EXTERNAL | DTE | PLEXUS MANUFACTURING SDN. BHD | 5392 | 00643169508767 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |