FDA Adverse Event
Malfunction
Summary report: N
PROMOTE ACCEL CRT-D, DF4 CONNECTOR
MDR report key: 2984512
·
Received February 28, 2013
Report
- Report Number
- 2938836-2013-00555
- Event Type
- Malfunction
- Date Received
- February 28, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NIK
- PMA / PMN Number
- P030054
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED NO COMMUNICATION COULD BE ESTABLISHED BETWEEN THE DEVICE AND THE PROGRAMMER UPON RECEIPT. LOW BATTERY VOLTAGE WAS OBSERVED.WITH ANOTHER BATTERY ATTACHED, THE DEVICE FUNCTIONED NORMALLY; NO HIGH CURRENT WAS DETECTED DURING TESTING AND THE POWER CONSUMPTION WAS NORMAL. THE ORIGINAL BATTERY WAS SENT TO THE VENDOR FOR FURTHER EVALUATION AND AN INTERNAL BATTERY ANOMALY WAS FOUND TO BE THE CAUSE OF THE PREMATURE BATTERY DEPLETION AND INABILITY TO COMMUNICATE.
Description of Event or Problem · 1
IT WAS REPORTED THAT PREMATURE BATTERY DEPLETION WAS SUSPECTED. THE DEVICE COULD NOT BE INTERROGATED. DEVICE WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 88502 | PROMOTE ACCEL CRT-D, DF4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD3215-36Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |