PULSE-GENERATOR, PACEMAKER, EXTERNAL
Report
- Report Number
- 2183613-2012-02040
- Event Type
- Malfunction
- Date Received
- October 31, 2012
- Date of Event
- October 2, 2012
- Report Date
- November 12, 2012
- Manufacturer
- MEDTRONIC MILACA, INC.
- Product Code
- DTE
- PMA / PMN Number
- P820003/S70
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT, THE BATTERY FLEX AND BATTERY CONTACTS WERE CONTAMINATED. IT WAS ALSO NOTED THAT THE TWO CONTROL KNOBS AND TWO KNOB SPRINGS WERE MISSING, UPPER CASE WAS BROKEN, LOWER CASE WAS BROKEN AND CONTAMINATED, THE BATTERY DRAWER AND BATTERY LATCHES WERE CONTAMINATED, AND THE RING COVER, TWO SIDE BAIL COVERS, RING AND TWO SIDE BAILS WERE MISSING.
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR WOULD NOT TURN ON AND HAD MISSING KNOBS. THE GENERATOR WAS RETURNED FOR SERVICE. IT WAS INDICATED ON THE RETURN PAPERWORK THAT THERE WERE NO PATIENT COMPLICATIONS ASSOCIATED WITH THIS EVENT.
IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR WOULD NOT TURN ON AND HAD MISSING KNOBS. THE GENERATOR WAS RETURNED FOR SERVICE. IT WAS INDICATED ON THE RETURN PAPERWORK THAT THERE WERE NO PATIENT COMPLICATIONS ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PULSE-GENERATOR, PACEMAKER, EXTERNAL | DTE | MEDTRONIC MILACA, INC. | 5348 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |