FDA Adverse Event
Injury
Summary report: N
EPIC PLUS DR
MDR report key: 1831042
·
Received September 10, 2010
Report
- Report Number
- 2017865-2010-03645
- Event Type
- Injury
- Date Received
- September 10, 2010
- Date of Event
- July 8, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Adverse Event
- 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.
Additional Manufacturer Narrative · 1
THE REPORTED FIELD EVENT COULD NOT BE REPRODUCED IN THE LABORATORY. THE DEVICE TESTED NORMAL ON THE BENCH AND DURING AUTOMATED ELECTRICAL TESTING. THE CAUSE OF THE REPORTED ANOMALY COULD NOT BE DETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED THAT TESTING COULD NOT BE PERFORMED ON THE DEVICE DUE TO LOSS OF TELEMETRY. JUST PRIOR TO EXPLANT, THE DEVICE INTERROGATED NORMALLY. THE PATIENT WORKS IN AN OFFICE WHERE THERE IS A MILITARY RADIO ANTENNA.
Description of Event or Problem · 1
THE LEAD WAS CAPPED AND WILL NOT BE RETURNED FOR ANALYSIS.
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 |