FDA Adverse Event
Malfunction
Summary report: N
EPIC PLUS DR
MDR report key: 3220071
·
Received July 11, 2013
Report
- Report Number
- 2938836-2013-04683
- Event Type
- Malfunction
- Date Received
- July 11, 2013
- Date of Event
- May 9, 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 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 UNDERSENSING OF A SMALL R-WAVE WAS OBSERVED ON ONE EPISODE IN A STORED EGM WHICH DELAYED THERAPY DUE TO FALSE RETURN TO SINUS. THE SMALL R-WAVE WAS PRECEDED BY A HIGH-AMPLITUDE R-WAVE. THE DEVICE WAS REPROGRAMMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 320926 | EPIC PLUS DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | V-239 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |