BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW-IN

    MDR report key: 2051310 · Received April 12, 2011

    Report

    Report Number
    2649622-2011-05532
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    K896313
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 THERE WAS AN ATRIAL LEAD WARNING AND THE RIGHT ATRIUM (RA) LEAD HAD AN APPARENT LEAD INSULATION BREACH. THE RA 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. 4058M ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other (B)(4) IMPLANTABLE PULSE GENERATOR| (B)(4) IMPLANTABLE PACING LEAD