BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SECURA DR

    MDR report key: 1861662 · Received October 8, 2010

    Report

    Report Number
    6000144-2010-04762
    Event Type
    Malfunction
    Date Received
    October 8, 2010
    Date of Event
    June 30, 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
    PA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS INTERMITTENT CROSSTALK ON PROGRAMMING CHANGES. FOLLOWUP INFORMATION INDICATED THAT THE PATIENT RETURNED TO THE CLINIC ONE WEEK LATER TO HAVE THE DEVICE CHECKED, AND EVERYTHING WAS NORMAL. 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
    1 SECURA DR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D224DRG ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other 4076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD