FDA Adverse Event
Malfunction
Summary report: N
DUAL CHAMBER TEMPORARY PACEMAKER
MDR report key: 3220888
·
Received July 8, 2013
Report
- Report Number
- 3220888
- Event Type
- Malfunction
- Date Received
- July 8, 2013
- Date of Event
- May 14, 2013
- Report Date
- June 29, 2013
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- LWS
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- MI, US
Narratives
Description of Event or Problem · 1
EXTERNAL PACEMAKER FAILED TO PACE WITHOUT NOTICE. COMPRESSIONS WERE PERFORMED FOR UNDER ONE MINUTE. A NEW EXTERNAL PACEMAKER WAS OBTAINED AND PACING WAS RESUMED. PERFORMANCE TEST RUN AND PASSED. DURING TESTING LOW BATTERY INDICATOR COMES ON AND GOES OFF. BATTERY VOLTAGE 8.74 VOLTS. SPOKE WITH MEDTRONIC TECH SUPPORT ABOUT FINDINGS. THIS POSSIBLY SUGGESTS THAT THE BATTERY CONTACTS MAY BE WORN OR HAVE SOME CONTACT ISSUE GOING ON WITH THEM. LOW BATTERY INDICATOR SHOULD NOT COME ON UNTIL BATTERY REACHES 8.0 +/- 0.5 VOLTS.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?LIFE SUPPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 309315 | DUAL CHAMBER TEMPORARY PACEMAKER | PULSE-GENERATOR, PACEMAKER, EXTERNAL | LWS | MEDTRONIC, INC. | 5388 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 YR |