FDA Adverse Event
Malfunction
Summary report: N
PROMOTE Q CRT-D
MDR report key: 2984558
·
Received February 28, 2013
Report
- Report Number
- 2938836-2013-00558
- Event Type
- Malfunction
- Date Received
- February 28, 2013
- Date of Event
- April 21, 2012
- 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 THE REPORTED RAPID BATTERY DEPLETION FROM ERI TO EOS WAS CONFIRMED IN THE LABORATORY. THE DEVICE WAS TESTED MANUALLY ON THE BENCH AND USING AUTOMATED TEST EQUIPMENT AND NO HIGH CURRENT DRAIN SOURCES WERE OBSERVED. THE ORIGINAL BATTERY WAS SENT TO THE VENDOR FOR FURTHER EVALUATION AND NO BATTERY ANOMALIES THAT COULD LEAD TO INTERNAL LOADING WERE DETECTED. THE CAUSE OF THE RAPPID BATTERY DEPLETION COULD NOT BE DETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED THAT PREMATURE BATTERY DEPLETION WAS OBSERVED. DEVICE WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 87426 | PROMOTE Q CRT-D | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD3221-36 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR |