BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 1922992 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-13170
    Event Type
    Injury
    Date Received
    December 13, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 THE BIPOLAR IMPEDANCE ON THE ATRIAL LEAD WAS LOW, WHICH LED TO A LEAD WARNING. UPON AN IMPEDANCE INDUCED POLARITY SWITCH THE PATIENT EXPERIENCED POCKET STIMULATION. IT WAS ALSO NOTED THAT THE LEAD'S UNIPOLAR IMPEDANCE WAS HIGHER THAN ITS BIPOLAR IMPEDANCE. NOISE WAS OBSERVED DURING ATRIAL HIGH RATE EPISODES WHEN THE LEAD WAS IN THE UNIPOLAR CONFIGURATION. THE LEAD POLARITY WAS REPROGRAMMED TO BIPOLAR, AND REMAINS IN USE. NO FURTHER 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 79 YR Required Intervention 4024 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR