FDA Adverse Event
Malfunction
Summary report: N
PROMOTE PLUS CRT-D
MDR report key: 3220095
·
Received July 11, 2013
Report
- Report Number
- 2938836-2013-04514
- Event Type
- Malfunction
- Date Received
- July 11, 2013
- Date of Event
- May 23, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NIK
- PMA / PMN Number
- P030054
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Additional Manufacturer Narrative · 1
DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.
Additional Manufacturer Narrative · 1
THE REPORTED FIELD EVENTS OF PREMATURE BATTERY DEPLETION AND EXTENDED CHARGE TIME WERE NOT CONFIRMED. BASED ON DEVICE SETTINGS, A LONGEVITY CALCULATION WAS PERFORMED AND FOUND TO BE WITHIN EXPECTED LIMITS. THE DEVICE WAS TESTED ON THE BENCH AND IN THE AUTOMATED SYSTEM; NO ANOMALIES WERE FOUND AND THE DEVICE MET ALL SPECIFICATIONS. NO EXTENDED CHARGE TIMES WERE OBSERVED.
Description of Event or Problem · 1
NEW INFORMATION RECEIVED NOTES THAT THE DEVICE WAS EXPLANTED AND REPLACED.
Description of Event or Problem · 1
IT WAS REPORTED THAT PREMATURE BATTERY DEPLETION AND EXTENDED CHARGE TIME WERE OBSERVED. THE DEVICE WILL BE EXPLANTED. NO FURTHER INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 320946 | PROMOTE PLUS CRT-D | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD3211-36 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Required Intervention |