BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 2952723 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00674
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 29, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED IN SEGMENTS, ANALYZED, AND THE DISTAL CONDUCTOR WAS FLEXED AND FRACTURED. IT WAS NOTED THAT THERE WAS A COSMETIC WHITE SUBSTANCE ON THE OUTER INSULATION, THERE WAS BLOOD IN THE DISTAL CONDUCTOR (NOT OBSTRUCTED), THERE WAS COSMETIC ENVIRONMENTAL STRESS CRACKING ON THE OUTER INSULATION, AND THERE WAS COSMETIC METAL ION OXIDATION ON THE OUTER INSULATION.

    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).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD HAD HIGH THRESHOLD, NO SENSING OR PACING, AND WAS POSSIBLY FRACTURED. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57264 ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4067-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Hospitalization| R