BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIFY CRT-D

    MDR report key: 3500536 · Received December 4, 2013

    Report

    Report Number
    2938836-2013-09327
    Event Type
    Injury
    Date Received
    December 4, 2013
    Date of Event
    October 15, 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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    THE REPORTED FIELD EVENTS OF RESET AND THERAPY DELIVERY WERE CONFIRMED IN THE LABORATORY. REVIEW OF THE DEVICE IMAGE CONFIRMED THAT THE DEVICE WAS RESET TO BACKUP DFO MODE IN THE FIELD. THE RESET WAS CAUSED AFTER AN INTERRUPT FOR AN AUTOMATIC SENSITIVITY CONTROL CONFIGURATION MISMATCH HAD OCCURRED. WHILE IN BACKUP DFO MODE, THE DEVICE CHARGED 8 TIMES. SINCE EGMS ARE NOT STORED IN BACKUP DFO MODE, IT IS UNKNOWN IF THE DELIVERED THERAPY WAS APPROPRIATE. THE DEVICE WAS TESTED ON THE BENCH AS WELL AS USING AUTOMATED TEST EQUIPMENT AND NO ANOMALIES WERE DETECTED. THE ROOT CAUSE OF THE ASC CONFIGURATION MISMATCH COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT PRESENTED TO THE ER AFTER RECEIVING INAPPROPRIATE THERAPY, THE DEVICE WAS OBSERVED TO BE IN BACKUP VVI MODE. A DEVICE DOWNLOAD WAS PERFORMED SUCCESSFULLY AND THE BACKUP VVI STATUS WAS NOT RECEIVED. IT WAS LATER NOTED THAT THE PHYSICIAN ELECTED TO EXPLANT THE DEVICE DURING LEAD REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627395 UNIFY CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3231-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention (B)(4)