BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SENSE

    MDR report key: 2964528 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-02129
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    November 6, 2012
    Report Date
    November 6, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE LEAD TESTED WITH GOOD PARAMETERS, BUT WHEN IT WAS CONNECTED TO IMPLANTABLE PULSE GENERATOR (IPG), THE DEVICE DID NOT WORK. THE PHYSICIAN REPLACED THE DEVICE, AND THE NEW DEVICE DID NOT WORK EITHER. THE PHYSICIAN THEN TRIED TO PULL THE LEAD BACK INTO THE CONNECTOR, AND THE NEW DEVICE BEGAN TO WORK NORMALLY. AFTER IMPLANTATION, THE PHYSICIAN PROGRAMMED THE DEVICE AND THE VENTRICLE LEAD WAS NOT WORKING IN BIPOLAR MODE. THE LEAD REMAINS 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
    68470 CAPSURE SENSE ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407458

    Patients

    Seq Age Sex Outcome Treatment
    1