FDA Adverse Event
Death
Summary report: N
EPIC II PLUS DR
MDR report key: 2193666
·
Received August 5, 2011
Report
- Report Number
- 2017865-2011-05334
- Event Type
- Death
- Date Received
- August 5, 2011
- Date of Event
- January 8, 2011
- 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 Location
- NC
- 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 EXPIRED. NO INFORMATION WAS AVAILABLE CONCERNING THE PATIENT'S DEATH. THE PATIENT'S MEDICAL RECORDS CHART NOTED THAT THE PATIENT WAS DECEASED. THE PHYSICIAN ATTEMPTED UNSUCCESSFULLY TO REACH THE FAMILY FOR MORE INFORMATION. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE PATIENT'S DEATH WAS DEVICE RELATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 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 | 68 YR | Death | (B)(4) |