BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THINLINE

    MDR report key: 3092780 · Received May 3, 2013

    Report

    Report Number
    2124215-2013-07348
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    February 13, 2009
    Report Date
    May 17, 2013
    Manufacturer
    GUIDANT ANGLETON/ST. PAUL
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    EFFORTS TO OBTAIN ADDITIONAL PRODUCT ISSUE DETAILS WERE UNSUCCESSFUL. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEAD WAS GOING TO BE EXPLANTED DUE TO EROSION; HOWEVER, THE LEAD WAS SURGICALLY ABANDONED AND BECAME INFECTED. THE PATIENT PRESENTED RECENTLY FOR LEAD EXTRACTION AND IT WAS NOTED THAT SOME TYPE OF RUBBER BAND DEVICE WAS PUT ON THE LEAD FOR THE EXTRACTION PROCESS. THIS WAS VERY PAINFUL AND THIS DEVICE WAS CUT OFF. DURING THE EXTRACTION PROCEDURE, A TAMPONADE OCCURRED AND THE PATIENT REQUIRED SURGERY TO REPAIR THE RIGHT VENTRICLE. DETAILS REGARDING THE REPORTED CLINICAL OBSERVATIONS ARE NOT COMPLETE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193899 THINLINE IMPLANTABLE LEAD NVN GUIDANT ANGLETON/ST. PAUL 438-10

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization| L 438-10| 1232| 1297