BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA ASSURA MP ICD

    MDR report key: 7260784 · Received February 9, 2018

    Report

    Report Number
    2938836-2018-01306
    Event Type
    Injury
    Date Received
    February 9, 2018
    Date of Event
    January 29, 2018
    Report Date
    June 29, 2018
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    Z-0117-2017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PREMATURE BATTERY DEPLETION WAS CONFIRMED BY ANALYSIS. NO SOURCES OF HIGH CURRENT WERE NOTED. THE CAUSE OF THE PREMATURE BATTERY DEPLETION WAS CONSISTENT WITH LI CLUSTER FORMATION. FROM THESE ANALYSES, IN THE ABSENCE OF HIGH CURRENT DRAW, IT IS PROBABLE THAT THE PREMATURE BATTERY DEPLETION WAS CAUSED BY A LITHIUM CLUSTER INDUCED SHORT CIRCUIT. LI CLUSTERS ARE A KNOWN DEPLETION MECHANISM FOR THESE ADVISORY PRODUCTS THAT HAS BEEN INVESTIGATED AND ASSOCIATED WITH A FIELD ACTION IN OCTOBER 2016. CORRECTION: DEVICE AVAILABLE FOR EVALUATION SHOULD HAVE BEEN (B)(6) 2018 INSTEAD OF (B)(6) 2018. PMA/510(K) # SHOULD HAVE BEEN P030054.

    Description of Event or Problem · 1

    FOLLOWING THE BATTERY PERFORMANCE ALERT (BPA) ADVISORY, A BPA WAS RECEIVED BY THE CLINICIAN AND THE DEVICE WAS EXPLANTED. PATIENT WAS STABLE POST SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104449 QUADRA ASSURA MP ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD3371-40C 4396591

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R