BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 2953028 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00869
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    September 24, 2012
    Report Date
    November 21, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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. CONCOMITANT PRODUCTS: (B)(4) IMPLANTABLE PULSE GENERATOR 2012 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED TWO FALLS IN APPROXIMATELY TWO MONTHS THAT WERE NOT BELIEVED TO BE DEVICE RELATED OR CARDIAC IN NATURE. DURING AN OFFICE VISIT, INTERMITTENT UNDERSENSING WAS NOTED ON THE VENTRICULAR LEAD. THE LEAD PROGRAMMING WAS CHANGED FROM BIPOLAR TO UNIPOLAR, 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
    56754 ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407658

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR 4076 IMPLANTABLE PACING LEAD