FDA Adverse Event
Malfunction
Summary report: N
EPIC II PLUS DR
MDR report key: 3090195
·
Received May 2, 2013
Report
- Report Number
- 2938836-2013-01283
- Event Type
- Malfunction
- Date Received
- May 2, 2013
- Date of Event
- February 27, 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 DURING REGULAR FOLLOW UP, SESSION RECORDS REVEALED ONE EPISODE OF NOISE DUE TO T-WAVE OVERSENSING. THE NOISE WAS NOT REPRODUCIBLE WITH POCKET MANIPULATION. THE PATIENT CONDITION IS GOOD. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 192043 | EPIC II PLUS DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | V-258 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |