BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SENSE

    MDR report key: 2954718 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-02412
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    December 17, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, 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). CONCOMITANT PRODUCT: 6948-65 IMPLANTABLE TACHY LEAD 2005 (B)(6); MODEL 9529 IMPLANTABLE CARDIA MONITOR 2011 (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD SHOWED HIGH THRESHOLDS. THE LEAD WAS CAPPED 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
    58817 CAPSURE SENSE ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4574

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 7278 DEFIBRILLATOR