FDA Adverse Event
Injury
Summary report: N
CURRENT VR RF
MDR report key: 1073490
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02269
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- December 20, 2007
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. REVIEW OF QUALITY RECORDS THE DEVICE WAS FOUND TO BE ABOVE ELECTIVE REPLACEMENT INDICATOR (ERI). TESTING REVEALED NORMAL DEVICE CHARACTERISTICS. NO ANOMALOUS BEHAVIOR WAS OBSERVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE SYSTEM WAS REMOVED DUE TO INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CURRENT VR RF | IMPLANTIBLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1207-36 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |