FDA Adverse Event
Injury
Summary report: N
PROMOTE RF CRT-D
MDR report key: 3791013
·
Received May 5, 2014
Report
- Report Number
- 2938836-2014-10516
- Event Type
- Injury
- Date Received
- May 5, 2014
- Date of Event
- February 27, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NIK
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Additional Manufacturer Narrative · 1
ANALYSIS DID NOT CONFIRM THE PREMATURE BATTERY DEPLETION. BASED ON DEVICE SETTINGS, A LONGEVITY CALCULATION WAS PERFORMED AND FOUND TO BE WITHIN EXPECTED LIMITS. THE PREMATURE BATTERY DEPLETION OBSERVED IN THE FIELD WAS A DISCREPANCY IN THE BATTERY LONGEVITY ESTIMATE DUE TO A DIAGNOSTIC ANOMALY. THE DEVICE WAS TESTED ON THE BENCH AS WELL AS USING AUTOMATED TEST EQUIPMENT, AND NO ANOMALIES WERE FOUND. THE CAUSE OF THE DIAGNOSTIC ANOMALY COULD NOT BE DETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE EXHIBITED PREMATURE BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 269095 | PROMOTE RF CRT-D | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST. JUDE MEDICAL, INC., CRMD | 3213-36 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Required Intervention |