BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK PLUS

    MDR report key: 2040026 · Received April 5, 2011

    Report

    Report Number
    2124215-2011-01251
    Event Type
    Injury
    Date Received
    April 5, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 5, 2011
    Manufacturer
    HISTORICAL CPI ST. PAUL
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WILL NOT BE RETURNED. 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 THIS RIGHT VENTRICULAR DEFIBRILLATION LEAD WAS EXHIBITING LOW SHOCK IMPEDANCES WHEN DEFIBRILLATION THRESHOLD TESTING (DFT) WAS PERFORMED. PACING IMPEDANCES WERE ALSO NOTED TO HAVE TRENDED UPWARD SINCE DFTS WERE PERFORMED, HOWEVER REMAIN IN ACCEPTABLE RANGE. A COMMANDED SHOCK WAS PROVIDED AT A LOWER JOULE AND SHOCK IMPEDANCES WERE WITHIN AN ACCEPTABLE RANGE. THE PHYSICIAN ELECTED TO SURGICALLY ABANDON THE LEAD AND REPLACE IT WITH A NEW DEFIBRILLATION LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK PLUS IMPLANTABLE LEAD NVY HISTORICAL CPI ST. PAUL 0075

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention 0180| 1720| 0075| T177| E102| 1793