FDA Adverse Event
Injury
Summary report: N
PROMOTE RF CRT-D
MDR report key: 3080199
·
Received April 26, 2013
Report
- Report Number
- 2938836-2013-00937
- Event Type
- Injury
- Date Received
- April 26, 2013
- Date of Event
- March 4, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NIK
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE REPORTED PREMATURE BATTERY DEPLETION COULD NOT BE CONFIRMED IN THE LABORATORY. BASED ON PROGRAMMED SETTINGS AND USAGE DATA, A LONGEVITY CALCULATION WAS PERFORMED AND THE BATTERY WAS WITHIN NORMAL LONGEVITY ESTIMATES. DEVICE FUNCTION WAS NORMAL WHEN TESTED ON THE BENCH.
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING ROUTINE FOLLOW-UP, PREMATURE BATTERY DEPLETION WAS OBSERVED. THE PATIENT WAS ASYMPTOMATIC. THE DEVICE WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 182123 | PROMOTE RF CRT-D | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 3207-36 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Required Intervention |