FDA Adverse Event
Injury
Summary report: N
CURRENT PLUS DR, DF4 CONNECTOR
MDR report key: 3101144
·
Received May 9, 2013
Report
- Report Number
- 2938836-2013-01922
- Event Type
- Injury
- Date Received
- May 9, 2013
- Date of Event
- March 14, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ASYMPTOMATIC PATIENT PRESENTED FOR FOLLOW UP. THE PATIENT RECEIVED INAPPROPRIATE HV THERAPY. POST-SENSED T WAVE OVERSENSING WAS OBSERVED. DEVICE WAS REPROGRAMMED AND WILL BE MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 203700 | CURRENT PLUS DR, DF4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD2211-36Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention |