BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE EPI

    MDR report key: 3341695 · Received September 11, 2013

    Report

    Report Number
    2649622-2013-10947
    Event Type
    Malfunction
    Date Received
    September 11, 2013
    Date of Event
    August 15, 2013
    Report Date
    August 15, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P950024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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. CONCOMITANT MEDICAL PRODUCTS: 4968 IMPLANTABLE PACING LEAD, IMPLANTED (B)96) 2010. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TACHY LEAD, WHICH HAD BEEN IMPLANTED OUTSIDE THE HEART, IS FRACTURED. ADDITIONAL INFORMATION OBTAINED FROM THE PHYSICIAN INDICATED THAT THE FRACTURE WAS RELATED TO TRAUMA TO THE ABDOMEN AS THE CHILD WAS SWINGING ON A SWING ON THE ABDOMEN. IT WAS FURTHER REPORTED THE PACING LEAD HAD HIGH THRESHOLDS. THE LEADS WERE EXPLANTED AND REPLACED. THE REPLACEMENT PACING LEAD IS REPORTED TO HAVE HIGH BUT STABLE THRESHOLDS AND HIGH IMPEDANCE. IT IS NOTED BY THE PHYSICIAN THAT THE PATIENT HAS A HIGH AMOUNT OF SCAR TISSUE FROM NUMEROUS HEART SURGERIES. THE LEAD REMAINS IN USE AND FOLLOW UP INFORMATION NOTED NO FURTHER ISSUES RELATED TO THE LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455666 CAPSURE EPI ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4968-35

    Patients

    Seq Age Sex Outcome Treatment
    1 00007 YR