FDA Adverse Event
Injury
Summary report: N
CURRENT RF VR
MDR report key: 2242457
·
Received September 10, 2011
Report
- Report Number
- 2017865-2011-06002
- Event Type
- Injury
- Date Received
- September 10, 2011
- Date of Event
- June 30, 2011
- 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
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED THE ANOMALY OBSERVED IN THE FIELD WAS CONFIRMED IN THE LABORATORY. THE OUTPUT CIRCUITRY OF THE DEVICE WAS FOUND DAMAGED. IT IS BELIEVED THE LEADS ARCED, CAUSING A LOW IMPEDANCE PATH THAT RESULTED IN THE DAMAGE. ALL LOW VOLTAGE FUNCTIONS WERE NORMAL.
Description of Event or Problem · 1
IT WAS REPORTED THAT AN ALERT WAS RECEIVED FOR POSSIBLE OUTPUT CIRCUIT DAMAGE AND LOW LEAD IMPEDANCE. NOISE WAS OBSERVED WITH PROVOCATION TESTS AND SEVERAL NOISE EPISODES CLASSIFIED AS VF WERE STORED. DEVICE WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CURRENT RF VR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1207-36 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | 7000/65, (B)(4) |