FDA Adverse Event
Malfunction
Summary report: N
CURRENT PLUS VR
MDR report key: 3090178
·
Received May 2, 2013
Report
- Report Number
- 2938836-2013-01155
- Event Type
- Malfunction
- Date Received
- May 2, 2013
- Date of Event
- March 14, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- P910023
- Removal / Correction Number
- NA
- 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 DURING NORMAL FOLLOW UP, DEVICE INTERROGATION REVEALED AN ALERT FOR OUT OF RANGE HV LEAD IMPEDANCE ON RV-SVC AND SVC-CAN VECTORS. THE PHYSICIAN PROGRAMMED THE SVC VECTOR OFF. THE DEVICE REMAINS IMPLANTED. PATIENT CONDITION IS GOOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 192511 | CURRENT PLUS VR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD1211-36 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | (B)(4) |