BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 2965100 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-01590
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    December 13, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    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. (B)(4). CONCOMITANT PRODUCT: 6949-58 IMPLANTABLE TACHY LEAD (B)(6) 2007.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING A ROUTINE IN-OFFICE VISIT, INTERROGATION OF THE DEVICE SHOWED THAT THERE WAS NO ATRIAL CAPTURE. THERE WAS HIGH UNSTABLE THRESHOLDS, AND A INCREASE IN LEAD IMPEDANCE. REPROGRAMMING WAS DONE. 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
    67426 ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5554-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Hospitalization| R D154AWG DEFIBRILLATOR