BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIA DR

    MDR report key: 4831454 · Received June 10, 2015

    Report

    Report Number
    9614453-2015-01199
    Event Type
    Injury
    Date Received
    June 10, 2015
    Report Date
    April 9, 2015
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES; HOWEVER, IT IS SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S. THIS EVENT OCCURRED OUTSIDE THE US AND PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS POWER ON RESET (POR) ON THE DEVICE. THERE WAS LOSS OF DIAGNOSTIC DATA (CARDIAC COMPASS, RATE HISTOGRAM) AFTER RADIOTHERAPY. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377139 CARDIA DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND D384DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention