BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW-IN

    MDR report key: 1926168 · Received December 14, 2010

    Report

    Report Number
    2649622-2010-14205
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    June 9, 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
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 ATRIAL LEAD POLARITY SWITCHED FROM BIPOLAR TO UNIPOLAR, DUE TO LOW IMPEDANCE. IT WAS ALSO NOTED THAT THE LEAD IMPEDANCE IN UNIPOLAR CONFIGURATION WAS HIGHER THAN IN BIPOLAR, AND MULTIPLE ATRIAL HIGH RATE EPISODES WERE COLLECTED BY THE DEVICE AFTER THE LEAD POLARITY SWITCHED TO UNIPOLAR. 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 84 YR Other (B)(4) IMPLANTABLE PULSE GENERATOR| (B)(4) IMPLANTABLE PACING LEAD