BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 2951826 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00221
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    January 14, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P890003/S50
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THAT THE OUTER INSULATION WAS BREACHED (CLAVICLE-RIB CRUSH). IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED), THERE WAS BLOOD/BODY FLUID ON THE PROXIMAL CONDUCTOR (NOT OBSTRUCTED) AND THE OUTER INSULATION HAD A COSMETIC DEPRESSION.

    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 DURING A FOLLOW-UP VISIT THE LEAD'S IMPEDANCES INCREASED FOR BOTH THE ATRIAL AND VENTRICLE AND THAT THERE WAS NOISE. 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
    57645 ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5038-58

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R