BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT

    MDR report key: 2790991 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-15391
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    August 27, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S12
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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 PRESENTED TO THE EMERGENCY ROOM AFTER FALLING. IT WAS NOTED THAT THE FALL WAS ON THE SAME SIDE AS THE DEVICE AND THERE WAS A BRUISE AT THE DEVICE SITE. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD A HIGH SENSING INTEGRITY COUNTER MEASUREMENT AT THE TIME OF THE FALL. FOLLOW UP INFORMATION WAS OBTAINED AND IT WAS NOTED THAT THE PHYSICIAN BELIEVES THAT THE FALL HAS NO CORRELATION TO ANY DEVICE ISSUE. A DEVICE INTERROGATION WAS DONE AND NO OVERSENSING WAS NOTED AND ALL OTHER PARAMETERS CHECKED OUT AS NORMAL. NO INTERVENTION WAS DONE AND 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 75 YR Other (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB