BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUBQ

    MDR report key: 3993425 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02315
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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. CONCOMITANT PRODUCT : D314TRG ICD IMPLANTED 2012-(B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD WAS OVERSENSING ACTIVITY BEFORE AND AFTER THE R WAVES. THE PATIENT WAS NOTED TO BE VERY SICK, INTUBATED AND HAD SMALL INTRINSIC R WAVES; THE LEAD WAS SENSING THE R WAVES PROPERLY. THE LEAD 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
    471768 SUBQ DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC, INC. 6996SQ58

    Patients

    Seq Age Sex Outcome Treatment
    1 00027 YR 4196-88 LEAD