BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 3153773 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-06214
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    March 21, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. SDR303B IMPLANTABLE PULSE GENERATOR 2005-(B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROUTINE DEVICE CHANGE OUT THE RIGHT VENTRICULAR LEAD IMPEDANCE WAS TESTED AND THE BIPOLAR IMPEDANCE WAS HIGH. UNIPOLAR IMPEDANCE WAS WITHIN THE NORMAL RANGE. IT WAS DISCOVERED UPON CONTACTING THE CLINIC, THAT THE DEVICE HAD BEEN PROGRAMMED UNIPOLAR SINCE 2011. IT IS UNCLEAR AS TO THE EXACT DATE AND FOR WHAT REASON THE DEVICE WAS INITIALLY REPROGRAMMED. THE NEW DEVICE WAS IMPLANTED, PROGRAMMED THE RV LEAD TO UNIPOLAR, AND 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
    255287 CAPSURE SP ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4024

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Required Intervention 4558M IMPLANTABLE PACING LEAD