BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 2951539 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00129
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 1, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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. CONTINUED: 6949 IMPLANTABLE TACHY LEAD 2005 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS HIGH THRESHOLD ON THE RIGHT ATRIAL (RA) LEAD. IT WAS NOTED THE LEAD DISLODGED. 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
    56818 CAPSUREFIX ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5568-53

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR Hospitalization| R 7288 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)