BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXATIP

    MDR report key: 1991390 · Received February 15, 2011

    Report

    Report Number
    2182208-2011-00145
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    November 13, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P850089/S17
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 VENTRICULAR LEAD FRACTURED. THE LEAD WAS SURGICALLY ABANDONED 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 DEXATIP IMPLANTABLE PACING LEAD DTB MEDTRONIC, INC. 4162 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R