BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THINLINE

    MDR report key: 3213163 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09762
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 7, 2013
    Manufacturer
    GUIDANT ANGLETON/ST. PAUL
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE LEAD IS NOT ABLE TO BE RETURNED, THE CLINICAL OBSERVATIONS CANNOT BE CONFIRMED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE ROUTINE DEVICE REPLACEMENT PROCEDURE, THIS CHRONIC RIGHT VENTRICULAR (RV) LEAD WAS DISCONNECTED FROM THE OLD DEVICE WITHOUT ISSUE. THE LEAD WAS TESTED ON THE PACING SYSTEM ANALYZER (PSA) WITH GOOD MEASUREMENTS, AND WAS THEN CONNECTED TO THE NEW DEVICE. HOWEVER, WHEN THE PHYSICIAN GENTLY TUGGED ON THE LEAD TO ENSURE A COMPLETE CONNECTION, THE LEAD BECAME STRETCHED. THE AREA BETWEEN THE INSULATION AND TERMINAL PIN WAS SEPARATED AND THE CONDUCTOR COILS APPEARED TO BE STRETCHED. THE PHYSICIAN QUESTIONED THE INTEGRITY OF THE LEAD. A NEW COMPETITIVE RV LEAD WAS IMPLANTED AND THIS LEAD WAS SURGICALLY ABANDONED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314073 THINLINE IMPLANTABLE LEAD NVN GUIDANT ANGLETON/ST. PAUL 430-10

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR MISMATCH| 430-10| 292-09X