BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 2952395 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00563
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    May 24, 2012
    Report Date
    November 15, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P890003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT A DEVICE CHECK IT WAS FOUND THAT THE LEAD POLARITY HAD BEEN CHANGED BY THE LEAD MONITOR FUNCTION DUE TO ABNORMAL LEAD IMPEDANCE. IT WAS NOTED THAT WHEN THE LEAD POLARITY WAS CHANGED TO BI-POLAR OVERSENSING AND NOISE WERE FOUND. THE LEAD REMAINS IN USE BUT IS SCHEDULED TO BE REPLACED IN THE NEXT WEEK. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55841 ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5038-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR