BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNIFY CRT-D

    MDR report key: 2925819 · Received January 22, 2013

    Report

    Report Number
    2017865-2013-01074
    Event Type
    Death
    Date Received
    January 22, 2013
    Date of Event
    December 31, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED LOW IMPEDANCE READING WAS VERIFIED AFTER REVIEW OF THE STORED DIAGNOSTIC DATA AND EGMS. THE DEVICE WAS TESTED ON THE BENCH AND IN THE AUTOMATED TEST EQUIPMENT SYSTEM AND NO DEVICE ANOMALIES WERE IDENTIFIED. THE CAUSE OF THE REPORTED FIELD EVENT AND LOW IMPEDANCE READING WAS DUE TO A LEAD TO CAN ABRASION.

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A VF EPISODE. THE DEVICE DELIVERED THERAPY BUT THE THERAPY DID NOT BREAK THE RHYTHM. LOW HVLI WAS ALSO OBSERVED DURING THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30932 UNIFY CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD3231-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death (B)(4)