BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RU PACING LEAD

    MDR report key: 1031645 · Received April 15, 2008

    Report

    Report Number
    1035166-2008-00009
    Event Type
    Malfunction
    Date Received
    April 15, 2008
    Date of Event
    March 24, 2008
    Report Date
    April 15, 2008
    Manufacturer
    OSCOR INC.
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER ATTEMPTED TO OBTAIN THE EVENT INFORMATION AND THE LEAD FOR ANALYSIS (IF EXPLANTED) BY SENDING LETTERS TO THE PHYSICIAN ON MARCH 25, 2008 AND APRIL 2, 2008. ON APRIL 9, 2008, THE PHYSICIAN RESPONDED BY FAXING THIS REPLY "WE ARE ONLY REQUIRED BY LAW TO RETAIN RECORDS FOR 7 YEARS. THEREFORE, THE RECORDS YOU ARE REQUESTING HAVE BEEN DESTROYED." AS A RESULT, THE CLINICAL OBSERVATIONS CANNOT BE CONFIRMED. THE EVENT WILL BE RE-EVALUATED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE. THE DEVICE HISTORY RECORDS AND THE COMPLAINT FILES OF THE LEAD MODEL WERE REVIEWED. NO TREND OF THE SAME OR SIMILAR TYPE WAS FOUND OR INDICATED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE PATIENT'S FAMILY ALLEGED THAT THE PATIENT HAS EXPERIENCED DIZZINESS DUE TO A BROKEN LEAD (SUGGESTING AN INTERMITTENT LEAD FRACTURE). THE SPECIFIC LEAD POSITION WAS NOT STATED; IMPLANT DATE IS UNKNOWN AND THE LEAD REMAINS IN SERVICE (IMPLANTED). NOTE: THE EVENT DATE IS UNKNOWN, SO THE DATE THE EVENT WAS RECEIVED IS BEING USED AS THE EVENT DATE. THE DEVICE REMAINS ACTIVELY IMPLANTED FOR APPROXIMATELY 14 YEARS, 11 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RU PACING LEAD PASSIVE FIXATION PACING LEAD DTB OSCOR INC. RU58TBV 11.5

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK