BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THINLINE

    MDR report key: 3052811 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04364
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    GUIDANT ANGLETON/ST. PAUL
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS SURGICALLY ABANDONED. 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 THE PATIENT IMPLANTED WITH THIS RIGHT VENTRICULAR (RV) LEAD UNDERWENT A NON-DEVICE RELATED PROCEDURE. IN ORDER TO COMPLETE THE PROCEDURE THIS RV LEAD REQUIRED REPOSITIONING. AT THE POST-OPERATION CHECK THE FOLLOWING DAY LOSS OF CAPTURE AT MAXIMUM OUTPUTS WAS OBSERVED. AN INVASIVE PROCEDURE WAS PERFORMED AND THIS LEAD WAS REPLACED WITH ANOTHER MANUFACTURER'S LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155071 THINLINE IMPLANTABLE LEAD NVN GUIDANT ANGLETON/ST. PAUL 430-10

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| L| R 294-09| S603| 438-10| 1296| 430-10