BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 1861821 · Received October 8, 2010

    Report

    Report Number
    2649622-2010-10084
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    July 7, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S2
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN INCREASE IN PACING THRESHOLD AND IMPEDANCE ON THE ATRIAL LEAD. EVENTUALLY THERE WAS NO ATRIAL CAPTURE. PATIENT'S DEVICE WAS REPROGRAMMED. TRACE ANKLE EDEMA WAS NOTED IN THE PATIENT AND HIS UNDERLYING RYTHM WAS COMPLETE HEART BLOCK WITH HEART RATES IN THE 40S. AT DEVICE CHANGE OUT THE LEAD WAS ANALYZED, UNIPOLAR IMPEDANCE WAS 1700 AND BIPOLAR IMPEDANCE WAS 1300. 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
    1 CAPSUREFIX IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4568 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention 4092 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR