FDA Adverse Event
Malfunction
Summary report: N
ELLIPSE DR
MDR report key: 3210425
·
Received July 8, 2013
Report
- Report Number
- 2938836-2013-03406
- Event Type
- Malfunction
- Date Received
- July 8, 2013
- Date of Event
- April 16, 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
- OH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED THE REPORTED FIELD EVENT OF EXTENDED CHARGE TIME WAS CONFIRMED IN THE LABORATORY VIA REVIEW OF PROGRAMMER PRINTOUTS. ANALYSIS OF THE DEVICE IDENTIFIED DAMAGE TO THE HIGH VOLTAGE CAPACITORS. THIS WOULD ACCOUNT FOR THE HIGH VOLTAGE CHARGE TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT PRIOR TO IMPLANT THE DEVICE TIMED OUT WHILE PERFORMING A ROUTINE CAPACITOR MAINTENANCE. THE DEVICE WAS NOT IMPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 311352 | ELLIPSE DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD2311-36 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR |