BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIFY CRT-D

    MDR report key: 3220350 · Received July 11, 2013

    Report

    Report Number
    2938836-2013-04548
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    May 29, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PACEMAKER DEPENDENT PATIENT PRESENTED FOR FOLLOW UP. VENTRICULAR OVERSENSING WAS OBSERVED. THE PATIENT UNDERWENT AN RF ABLATION TWO DAY PRIOR. THE DEVICE WAS REPROGRAMMED SUCCESSFULLY. DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320950 UNIFY CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD3235-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR