FDA Adverse Event
Malfunction
Summary report: N
CURRENT PLUS VR
MDR report key: 3101094
·
Received May 9, 2013
Report
- Report Number
- 2938836-2013-01901
- Event Type
- Malfunction
- Date Received
- May 9, 2013
- Date of Event
- February 20, 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 Location
- FL
- 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 AN ASYMPTOMATIC PATIENT PRESENTED IN CLINIC, INTERMITTENT UNDER SENSED PVCS WERE OBSERVED. IT WAS RECOMMENDED TO REPROGRAM THE DEVICE. HOWEVER, NO PROGRAMMING CHANGES WERE MADE TO THE DEVICE. THE DEVICE REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 203696 | CURRENT PLUS VR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD1211-36 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR |