FDA Adverse Event
Injury
Summary report: N
CURRENT RF VR
MDR report key: 2242432
·
Received September 10, 2011
Report
- Report Number
- 2017865-2011-05999
- Event Type
- Injury
- Date Received
- September 10, 2011
- Date of Event
- June 6, 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 IMPEDANCE ANOMALY WAS CONFIRMED IN THE LABORATORY. THE DEVICE WAS FOUND TO HAVE A BROKEN CASE WIRE INSIDE THE CAN, AFFE CTING RV TO CAN AND SVC TO CAN VECTORS. THE ONLY HV DISCHARGE WAS FROM RV TO SVC. THE OPEN WIRE CONNECTION COULD ACCOUNT FOR OUT OF RANGE HVLI MEASUREMENTS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT RECEIVED AN ALERT DUE TO OUT-OF-RANGE SHOCK IMPEDANCE. THE SYSTEM WAS EXPLANTED.
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 |