FDA Adverse Event
Malfunction
Summary report: N
EPIC II VR
MDR report key: 2984427
·
Received February 28, 2013
Report
- Report Number
- 2938836-2013-00588
- Event Type
- Malfunction
- Date Received
- February 28, 2013
- 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 Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE REPORTED FIELD EVENTS OF HIGH VOLTAGE CIRCUIT FAILURE AND EXTENDED CHARGE TIME COULD NOT BE CONFIRMED IN THE LABORATORY. NO ALERTS FOR HIGH VOLTAGE CIRCUIT FAILURE WERE OBSERVED UPON INTERROGATION OF THE DEVICE. DEVICE FUNCTION WAS NORMAL WHEN TESTED ON THE BENCH AND USING AUTOMATED TEST EQUIPMENT.
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 DURING FOLLOW-UP, HIGH CAPTURE THRESHOLD WAS OBSERVED ON THE RV LEAD. THE DEVICE HAD REACHED ERI AND AN ALERT FOR HIGH VOLTAGE CIRCUIT FAILURE AND EXTENDED CHARGE TIME WAS DISPLAYED. THE LEAD AND ICD WERE EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 88318 | EPIC II VR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | V-158 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 30 YR | (B)(4) |