FDA Adverse Event
Malfunction
Summary report: N
CURRENT PLUS VR, DF-4 CONNECTOR
MDR report key: 1895776
·
Received November 10, 2010
Report
- Report Number
- 2017865-2010-04669
- Event Type
- Malfunction
- Date Received
- November 10, 2010
- Date of Event
- August 9, 2010
- 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 ANALYSIS FOUND THE DEVICE TO EXHIBIT HIGH IMPEDANCE. ADDITIONAL TESTING ON THE BENCH AND ON AUTOMATED ELECTRICAL SYSTEM AS WELL AS EXTENSIVE TEMPERATURE CYCLING FOUND NO ANOMALIES. A ROOT CAUSE FOR THE HIGH IMPEDANCE COULD NOT BE DETERMINED.
Description of Event or Problem · 1
THIS REPORT IS TO ADVISE OF AN EVENT OBSERVED DURING ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CURRENT PLUS VR, DF-4 CONNECTOR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | CD1211-36Q | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |