BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREEPI

    MDR report key: 3934345 · Received July 15, 2014

    Report

    Report Number
    2182208-2014-01845
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 20, 2014
    Manufacturer
    RICE CREEK MFG
    Product Code
    DTB
    PMA / PMN Number
    P950024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. PRODUCT ID: 4968-35, IMPLANTED: (B)(6) 2003. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BOTH THE ATRIAL AND VENTRICULAR LEADS WERE FRACTURED. THE LEADS WERE "MENDED" AT THE INSULATION AND REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412026 CAPSUREEPI ELECTRODE, PACEMAKER, PERMANENT DTB RICE CREEK MFG 4968-35

    Patients

    Seq Age Sex Outcome Treatment
    1 00017 YR Hospitalization| R ADDRL1 IPG