BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELLIPSE VR

    MDR report key: 4031761 · Received August 22, 2014

    Report

    Report Number
    2938836-2014-14769
    Event Type
    Injury
    Date Received
    August 22, 2014
    Date of Event
    June 18, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    THE REPORTED FIELD EVENT OF LONG CHARGE TIME WAS CONFIRMED IN THE LABORATORY VIA REVIEW OF THE DEVICE IMAGE. THE HV CAPACITORS WERE SENT TO THE MANUFACTURING SITE FOR FURTHER EVALUATION AND AN INTERNAL HV CAPACITOR ANOMALY WAS FOUND. THE CAUSE OF THE LONG CHARGE TIME WAS AN INTERNAL HV CAPACITOR ANOMALY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ALERT FOR EXTENDED CHARGE TIME WAS OBSERVED. THE DATE STAMP OF THE ALERT WAS PRIOR TO IMPLANT. A CAPACITOR MAINTENANCE WAS PERFORMED AND THE CHARGE TIME WAS IN NORMAL LIMITS. HOWEVER, THE ALERT WAS STILL PRESENT. THE ALERT DISAPPEARED AFTER TWO MORE CHARGES. IT WAS SUSPECTED THAT CHARGING MIGHT BE UNRELIABLE AND THE DEVICE WAS EXPLANTED AND REPLACED. PATIENT WAS DOING WELL WITH NO REPORTED SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510012 ELLIPSE VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD1411-36C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention