FDA Adverse Event
Injury
Summary report: N
EPIC PLUS DR
MDR report key: 1073576
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02460
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- May 20, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Additional Manufacturer Narrative · 1
THE FIELD EVENT OF INAPPROPRIATE THERAPY AND NOISE WAS VERIFIED VIA THE STORED EGMS. THE DEVICE WAS TESTED ON THE BENCH AND ON THE AUTOMATED ELECTRICAL TEST SYSTEM. ALL DEVICE FUNCTIONS WERE NORMAL.
Description of Event or Problem · 1
IT WAS REPORTED THAT OVERSENSING OF NOISE ON THE VENTRICULAR CHANNEL RESULTED IN INAPPROPRIATE HIGH VOLTAGE THERAPY. THE PHYSICIAN SUSPECTED A SETSCREW ISSUE AND OPENED THE POCKET TO TIGHTEN IT DOWN. THE NOISE COULD NOT BE REPRODUCED. THE DEVICE WAS REPROGRAMMED AND THE SYSTEM REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EPIC PLUS DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | V-239 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |