FDA Adverse Event
Injury
Summary report: N
PROMOTE PLUS CRT-D, DF4 CONNECTOR
MDR report key: 3220127
·
Received July 11, 2013
Report
- Report Number
- 2938836-2013-04519
- Event Type
- Injury
- Date Received
- July 11, 2013
- Date of Event
- April 15, 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
- GA
- 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 AN ASYMPTOMATIC PATIENT RECEIVED INAPPROPRIATE THERAPY SHOCKS DUE TO POST-SENSED T-WAVE OVERSENSING. THE OVERSENSING WAS NOTED ON A STORED EGM. THE PATIENT WAS FOUND TO HAVE ELECTROLYTE IMBALANCES. PROGRAMMING CHANGES WERE MADE AND THE OVERSENSING WAS RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 319723 | PROMOTE PLUS CRT-D, DF4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | NIK | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD3211-36Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Required Intervention |