BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIFY ASSURA CRT-D RF HV

    MDR report key: 4863912 · Received June 23, 2015

    Report

    Report Number
    2938836-2015-27284
    Event Type
    Injury
    Date Received
    June 23, 2015
    Date of Event
    May 26, 2015
    Report Date
    May 26, 2015
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NIK
    PMA / PMN Number
    P970013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EXTENDED CHARGE TIME WAS CONFIRMED IN THE LABORATORY. THE DEVICE WAS TESTED ON THE BENCH AS WELL AS USING AUTOMATED TEST EQUIPMENT, AND NO ANOMALY WAS FOUND. THE CAPACITORS WERE RETURNED TO THE MANUFACTURER FOR FURTHER ANALYSIS AND AN INTERNAL CAPACITOR ANOMALY WAS FOUND TO BE THE CAUSE OF THE REPORTED EXTENDED CHARGE TIME.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ASYMPTOMATIC PATIENT PRESENTED IN CLINIC AFTER RECEIVING AN ALERT FOR THE CAPACITOR CHARGE TIME LIMIT HAVING BEEN REACHED. DURING ATTEMPTED CAPACITOR MAINTENANCES IN-CLINIC THE DEVICE EXHIBITED LOSS OF TELEMETRY AND CONTINUED CAPACITOR CHARGE TIME OUTS. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404990 UNIFY ASSURA CRT-D RF HV IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CD3357-40Q 4385209

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention