BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE EPI

    MDR report key: 3190487 · Received June 26, 2013

    Report

    Report Number
    2182208-2013-01858
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Report Date
    January 5, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    DTB
    PMA / PMN Number
    P950024
    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 PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND THE DISTAL CONDUCTOR OF THE LEAD DEVELOPED A FRACTURE DUE TO FLEXING WHILE IN VIVO. (B)(4): PRODUCT ID ADDR01, IMPLANTED: (B)(6) 2011; PRODUCT ID 4968-25, IMPLANTED: (B)(6) 2006.

    Description of Event or Problem · 1

    THE LEAD WAS RETURNED TO THE MANUFACTURER AFTER BEING EXPLANTED DUE TO MEDICAL JUDGMENT. THE LEAD SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER¿S ANALYSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290887 CAPSURE EPI ELECTRODE, PACEMAKER, PERMANENT DTB RICE CREEK MFG 4968-25

    Patients

    Seq Age Sex Outcome Treatment
    1 00007 YR