BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 4160585 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-11852
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    July 14, 2014
    Report Date
    July 18, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE PROXIMAL SEGMENT OF THE LEAD MEASURING 12 CM WAS RETURNED, ANALYZED, AND THE OUTER INSULATION OF THE LEAD DEVELOPED A BREACH DUE TO ENVIRONMENTAL STRESS CRACKING WHILE IN VIVO. 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. CONCOMITANT MEDICAL PRODUCTS: ADDRL1, IPG, IMPLANTED: 2006-03-20 (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD AND ATRIAL LEADS ENCOUNTERED INSULATION FAILURE WITH EXHIBITED LOW IMPEDANCE AND HIGH THRESHOLDS. THE RV AND ATRIAL LEADS WERE 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
    641663 CAPSURE SP ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4524

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 4024 LEAD