FDA Adverse Event
Injury
Summary report: N
CURRENT RF VR
MDR report key: 3210636
·
Received July 8, 2013
Report
- Report Number
- 2938836-2013-03201
- Event Type
- Injury
- Date Received
- July 8, 2013
- Date of Event
- May 17, 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
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE OR FOR A DEVICE CHANGEOUT. AN ALERT MESSAGE FOR POSSIBLE OUTPUT CIRCUIT DAMAGE WAS OBSERVED. NORMAL ELECTRICAL MEASUREMENTS WERE NOTED. HV CAPACITOR TESTING WAS RECOMMENDED. THE DEVICE WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 309216 | 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 |