BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 2955152 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-00833
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    November 21, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BOTH THE ATRIAL AND VENTRICULAR LEADS HAD HIGH THRESHOLDS. INITIALLY THE DEVICE WAS REPROGRAMMED TO VVI MODE. LATER THE VENTRICULAR LEAD WAS CAPPED AND REPLACED. THE ATRIAL LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS ARESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59494 CAPSUREFIX ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5568-53

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR