BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT

    MDR report key: 2790692 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14760
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    July 5, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S12
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WENT TO THE CLINIC DUE TO COUGHING. IT WAS NOTED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD HAD INCREASED IMPEDANCE AND OVERSENSING. 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
    1 SPRINT IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6942

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other 7231CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB