FDA Adverse Event
Injury
Summary report: N
EPIC II PLUS DR
MDR report key: 4261374
·
Received January 11, 2014
Report
- Report Number
- 2938836-2014-03838
- Event Type
- Injury
- Date Received
- January 11, 2014
- Date of Event
- June 18, 2012
- Manufacturer
- ST. JUDE MEDICAL INC., CRMD
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INAPPROPRIATE THERAPY. IT WAS DISCUSSED THAT THE DEVICE SETTINGS SHOULD BE ADJUSTED TO PREVENT THE INAPPROPRIATE THERAPY. THE DEVICE REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 22355 | EPIC II PLUS DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, LWS | LWS | ST. JUDE MEDICAL INC., CRMD | V-258 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR |