BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW-IN

    MDR report key: 1990159 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-01856
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    August 1, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    K940703
    Removal / Correction Number
    ASKU
    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 LEAD POLARITY SWITCHED TO UNIPOLAR. AFTER BEING REPROGRAMMED BACK TO BIPOLAR, THE LEAD POLARITY AGAIN SWITCHED TO UNIPOLAR. THE UNIPOLAR IMPEDANCE WAS HIGHER THAN THE BIPOLAR. THE PHYSICIAN WANTED TO LEAVE THE LEAD IN UNIPOLAR CONFIGURATION AND WILL CONSIDER REVISING ATRIAL LEAD AT DEVICE CHANGE OUT. 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
    1 SCREW-IN IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4558M ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other 4024 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR