BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIFY QUADRA CRT-D

    MDR report key: 3339867 · Received September 10, 2013

    Report

    Report Number
    2938836-2013-06438
    Event Type
    Injury
    Date Received
    September 10, 2013
    Date of Event
    June 11, 2013
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED FIELD EVENTS OF BACKUP VVI AND OUTPUT ANOMALY WERE CONFIRMED IN THE LABORATORY. UPON RECEIPT, THE DEVICE WAS INTERROGATED AND FOUND IN BACKUP VVI, CONSISTENT WITH BEING CAUSED BY EXTERNAL DEFIBRILLATION. BENCH TESTING INDICATED THAT A HV OUTPUT TRANSISTOR WAS DAMAGED DUE TO HV DELIVERY INTO LOW IMPEDANCE. THE CAUSE OF THE LOW IMPEDANCE OUTPUT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT DEVICE UPGRADE DUE TO NORMAL ERI, AFTER CLOSING THE POCKET, DFT TESTING WAS UNSUCCESSFUL IN RESCUING THE PATIENT. CHARGES AT HIGHER ENERGY WERE ABORTED AND PATIENT WAS EXTERNALLY RESCUED. THE ICD SHOWED AN ALERT FOR POSSIBLE OUTPUT CIRCUIT DAMAGE. ADDITIONAL DFT TESTING WAS ALSO UNSUCCESSFUL AND PATIENT WAS EXTERNALLY RESCUED AGAIN. DEVICE WENT INTO BACK UP MODE DUE TO EXTERNAL DEIB. PHYSICIAN ELECTED TO REPLACE BOTH THE LEAD AND THE ICD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452145 UNIFY QUADRA CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3249-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention (B)(4)