FDA Adverse Event
Injury
Summary report: N
EPIC DR
MDR report key: 1223284
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03694
- Event Type
- Injury
- Date Received
- November 10, 2008
- Date of Event
- September 10, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMAP910023
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- TX
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ASSOCIATED RV LEAD MDR#2017865-2008-03692
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 DEVICE PRESENTED WITH INAPPROPRIATE THERAPIES, AND HV LEAD IMPEDANCE OUT OF RANGE. NOISE WAS OBSERVED ON BOTH ATRIAL AND VENTRICULAR CHANNELS WHEN ATTEMPTED TO PERFORM AN HVLIC. THE NOISE APPEARED WHILE THE DEVICE WAS CHARGING. THE PATIENT WENT INTO CARDIAC ARREST. A REPLACEMENT WAS PENDING UPON IMPROVEMENT OF PATIENTS CONDITION. LATER, IT WAS REPORTED THAT THE PATIENT REQUESTED TO BE DNR. THE DEVICE WAS TURNED OFF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EPIC DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | V-235 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Hospitalization| R |