BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 2951860 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00274
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    January 22, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039/S2
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: (B)(4): THE FULL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND THE DISTAL CONDUCTOR WAS FOUND TO BE FRACTURED, FLEXED, AND CUT. IT WAS NOTED THAT THE LEAD CONDUCTOR WAS NOT OBSTRUCTED; HOWEVER BLOOD WAS NOTED ON THE DISTAL AND PROXIMAL PORTIONS OF THE LEAD. THE VISUAL SUMMARY INDICATED THE LEAD WAS STRETCHED AND THE DISTAL AND PROXIMAL PORTIONS WERE NOTED AS PULLED/STRETCHED/OVERSTRESSED. AN INSULATION CUT AND A WHITE SUBSTANCE WERE NOTED ON THE OUTER INSULATION OF THE LEAD. THE INNER AND OUTER INSULATION WERE FOUND TO BE TORN AND A COSMETIC OUTER INSULATION DEPRESSION WAS NOTED. THE HELIX WAS FOUND TO BE PULLED/STRETCHED/ OVERSTRESSED. THE PROXIMAL LEAD SEGMENT WAS REPORTED TO BE KINKED/BUCKLED. THE DISTAL ELECTRODE WAS COVERED WITH BLOOD. THE OUTER INSULATION WAS FOUND TO BE PULLED/STRETCHED/OVERSTRESSED.

    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).

    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 THERE WAS OVERSENSING OBSERVED IN THE RIGHT VENTRICULAR LEAD. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57758 CAPSUREFIX ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5068

    Patients

    Seq Age Sex Outcome Treatment
    1 00026 YR Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR