FDA Adverse Event
Injury
Summary report: N
EPIC PLUS DR
MDR report key: 1223114
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03748
- Event Type
- Injury
- Date Received
- November 10, 2008
- Date of Event
- September 23, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMAP910023
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
TESTING ON THE BENCH AND ON THE AUTOMATED ELECTRICAL TEST SYSTEM REVEALED NORMAL DEVICE FUNCTION. IT IS BELIEVED THAT THE CAUSE OF THE INAPPROPRIATE THERAPIES WAS DUE TO NOISE FROM AN INTERMITTENT CONNECTION OF ONE OF THE VENTRICULAR (IS-1) SET SCREWS.
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED: DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY DUE TO OVERSENSED NOISE ON THE VENTRICULAR CHANNEL. THE NOISE WAS REPRODUCED ON THE RV CHANNEL WITH POCKET MANIPULATION. THE PHYSICIAN SUSPECTED A LOOSE SET SCREW. WHEN THE POCKET WAS OPENED, THE LEAD TESTED NORMAL AND THE NOISE COULD NOT BE REPRODUCED. THEREFORE, THE DEVICE WAS REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EPIC PLUS DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | V-239 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention |