BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURA DR

    MDR report key: 1791375 · Received August 10, 2010

    Report

    Report Number
    6000144-2010-03101
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    April 19, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S114
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PREVIOUS EXPERIENCE FROM A RETRO REVIEW FOR DEVICES STILL IN USE HAS BEEN INCORPORATED INTO THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WIRELESS CAPABILITY IN THE DEVICE IS NOT AVAILABLE AND THE DEVICE IS BEEPING. THE MOST RECENT CARELINK TRANSMISSION DOES NOT INDICATE THAT AN ELECTRICAL RESET OCCURRED. THE PATIENT IS PRESENTLY RECEIVING RADIATION THERAPY. PREVIOUS EXPERIENCE ON THIS DEVICE INCLUDES A POWER ON RESET, AND THAT THE PATIENT HAD RADIATION THERAPY WEEKS PRIOR TO THE REPORT WHERE THE WIRELESS CAPABILITY IN THE DEVICE WAS DETERMINED TO BE NO LONGER AVAILABLE. CURRENTLY, THE DEVICE IS STILL 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
    1 SECURA DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D224DRG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other 6947 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD