FDA Adverse Event
Injury
Summary report: N
PROMOTE ACCEL CRT-D
MDR report key: 1954744
·
Received January 10, 2011
Report
- Report Number
- 2017865-2011-00515
- Event Type
- Injury
- Date Received
- January 10, 2011
- Date of Event
- October 25, 2010
- 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 Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE BATTERY CURRENT DRAIN WAS HIGH AND THE DEVICE EXHIBITED PREMATURE BATTERY DEPLETION DUE TO HIGH ATRIAL AND VENTRICULAR THRESHOLDS. THE LEADS WERE COMPETITOR LEADS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROMOTE ACCEL CRT-D | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD3215-36 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | (B)(4) |