BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE EPI

    MDR report key: 3243326 · Received July 23, 2013

    Report

    Report Number
    2182208-2013-01885
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    May 4, 2012
    Report Date
    May 6, 2013
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P950024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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. PRODUCT EVENT SUMMARY: (B)(4) - THE PARTIAL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND THE OUTER INSULATION OF THE LEAD DEVELOPED A BREACH DUE TOA DEPRESSION WHILE IN VIVO. THERE WAS BLOOD ON THE PROXIMAL CONDUCTOR OF THE LEAD AND IT WAS NOT OBSTRUCTED, THERE WAS BLOOD ON THEDISTAL CONDUCTOR OF THE LEAD AND IT WAS NOT OBSTRUCTED, AND THE OUTER INSULATION OF THE LEAD DEVELOPED A COSMETIC DEPRESSION WHILE IN VIVO. CONCOMITANT PRODUCTS: KDR901 IMPLANTABLE PULSE GENERATOR (IPG), IMPLANTED: (B)(6) 2003; 4968-25 IMPLANTABLE PACING LEAD, IMPLANTED: (B)(6) 2003. (B)(4).

    Description of Event or Problem · 1

    THE LEADS WERE RETURNED TO THE MANUFACTURER WITH NO INFORMATION, WERE ANALYZED AND TESTED OUT OF SPECIFICATION. ADDITIONAL INFORMATION OBTAINED NOTED THAT THE LEADS WERE FRACTURED WHEN THE PHYSICIAN ATTEMPTED TO FREE THEM UP DURING DEVICE REPLACEMENT. NO PERFORMANCE ALLEGATIONS WERE KNOWN PRIOR TO PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344195 CAPSURE EPI ELECTRODE, PACEMAKER, PERMANENT DTB MEDTRONIC, INC. 4968-25

    Patients

    Seq Age Sex Outcome Treatment
    1 00014 YR Hospitalization| R