FDA Adverse Event
Malfunction
Summary report: N
ELLIPSE DR, DF4 CONNECTOR
MDR report key: 3090209
·
Received May 2, 2013
Report
- Report Number
- 2938836-2013-01207
- Event Type
- Malfunction
- Date Received
- May 2, 2013
- Date of Event
- February 25, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- 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 DURING FOLLOW UP A NON-SUSTAINED RV LEAD NOISE DUE TO T-WAVE OVERSENSING WAS OBSERVED ON EGM EPISODE. THE DEVICE WAS REPROGRAMMED AND REMAINS IMPLANTED.
Description of Event or Problem · 1
NEW INFORMATION NOTED THAT NON SUSTAINED LEAD NOISE EPISODE WAS OBSERVED DUE TO PVC BEING UNDERSENSED ON THE DISCRIMINATION CHANNEL. THE PATIENT WILL BE MONITORED WITH NO CHANGE MADE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 191367 | ELLIPSE DR, DF4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD2311-36Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR |