BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 1864636 · Received October 12, 2010

    Report

    Report Number
    2649622-2010-10709
    Event Type
    Injury
    Date Received
    October 12, 2010
    Date of Event
    July 26, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LEAD WARNING HAD OCCURRED, LEAD IMPEDANCE WAS LOW, THRESHOLD HAD INCREASED, AND THAT THE PATIENT IS UNABLE TO TOLERATE UNIPOLAR PACING DUE TO POCKET STIMULATION. THE LEAD IS STILL 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
    1 CAPSUREFIX IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4068 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 96 YR Other E2SR01 IMPLANTABLE PULSE GENERATOR