BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELLIPSE DR

    MDR report key: 3872906 · Received June 13, 2014

    Report

    Report Number
    2938836-2014-11860
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    April 14, 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
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HEARD A POPPING NOISE, THE DEVICE DELIVERED A PATIENT NOTIFIER ALERT FOR A LONG CHARGE TIME. THE CHARGE TIME WAS MEASURED IN CLINIC AND WAS FOUND TO BE VARIABLE. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349167 ELLIPSE DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2311-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention