FDA Adverse Event
Malfunction
Summary report: N
EXTERNAL PULSE GENERATOR
MDR report key: 2812805
·
Received October 31, 2012
Report
- Report Number
- 2183613-2012-01882
- Event Type
- Malfunction
- Date Received
- October 31, 2012
- Date of Event
- October 9, 2012
- Manufacturer
- MEDTRONIC MILACA INC.
- Product Code
- DTE
- PMA / PMN Number
- P820003/S72
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, 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.
Description of Event or Problem · 1
IT WAS REPORTED BY THE CLINICIAN THAT THE EXTERNAL PULSE GENERATOR (EPG) WAS IN FOR NORMAL PREVENTATIVE MAINTENANCE (PM) AND IT WAS DISCOVERED THAT THE VENTRICULAR-SIDE OUTPUT CONNECTOR WAS BROKEN. TECHNICAL SUPPORT (TS) PROVIDED PART NUMBERS FOR THE OUTPUT CONNECTOR AND THE O-RING. IT WAS SUGGESTED THAT THE GENERATOR BE TESTED AFTER REPAIR. IT WAS INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXTERNAL PULSE GENERATOR | DTE | MEDTRONIC MILACA INC. | 5388 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |