BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THINLINE II

    MDR report key: 2911902 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16599
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 27, 2012
    Report Date
    December 20, 2012
    Manufacturer
    GUIDANT ANGLETON/ST. PAUL
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, ANALYSIS DETERMINED THAT THIS LEAD WAS FRACTURED. THERE WAS ALSO LEAD ON LEAD ABRASION OBSERVED. NO THERAPY WAS AVAILABLE AT THE TIME OF EXPLANT. NO FURTHER ANALYSIS WAS PERFORMED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD STOPPED FUNCTIONING AS A RESULT THE PATIENT'S GENERATOR WAS PROGRAMMED TO PACE/SENSE IN THE VENTRICLE ONLY. THE LEAD WAS LATER EXTRACTED. NO FURTHER INFORMATION HAS BEEN REVEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16521 THINLINE II IMPLANTABLE LEAD NVN GUIDANT ANGLETON/ST. PAUL 438-25-52

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| L| R 4055| 438-25-52| 1286