BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELLIPSE VR ICD

    MDR report key: 6444971 · Received March 29, 2017

    Report

    Report Number
    2938836-2017-19971
    Event Type
    Injury
    Date Received
    March 29, 2017
    Date of Event
    March 6, 2017
    Report Date
    January 19, 2018
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    Z-2572-2014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS FOUND THE REPORTED EXTENDED 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 CAPACITOR ANOMALY WAS FOUND. THE ROOT CAUSE OF THE EXTENDED CHARGE TIME WAS AN INTERNAL HV CAPACITOR ANOMALY. ADDITIONAL INFORMATION: PMA/510(K) # - P910023.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD DELIVERED A PATIENT NOTIFIER FOR LONG CHARGE TIME. THE PATIENT WAS BROUGHT INTO CLINIC AND ANOTHER LONG CHANGE TIME WAS REACHED. DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225027 ELLIPSE VR ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD1311-36Q 4108865

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention