FDA Adverse Event
Injury
Summary report: N
EPIC PLUS VR
MDR report key: 1954711
·
Received January 21, 2011
Report
- Report Number
- 2017865-2011-00565
- Event Type
- Injury
- Date Received
- January 21, 2011
- Date of Event
- October 30, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY
- 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 THE PATIENT CAME IN TO ER AFTER RECEIVING A SHOCK. THE DEVICE WAS FOUND TO BE IN RESET MODE WITH NO DEFIB SUPPORT. IT WAS BELIEVED THAT A LEAD ANOMALY MAY HAVE BEEN THE CAUSE. THE LEAD BELONGS TO A COMPETITOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EPIC PLUS VR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | V-196 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Required Intervention | (B)(4) |