BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1771403 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-12561
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    June 10, 2010
    Report Date
    February 27, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS REPOSITIONED AND ALL MEASUREMENTS RETURNED TO AN ACCEPTABLE RANGE. THE LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS REPORTED.

    Additional Manufacturer Narrative · 1

    THE LEAD WAS SURGICALLY ABANDONED AND 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 CRM RECEIVED INFORMATION THAT THIS LEAD EXHIBITED INCREASED THRESHOLDS, DECREASED PACING IMPEDANCES AND DECREASED AMPLITUDES. A MICRODISLODGEMENT WAS SUSPECTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT TWO YEARS AND EIGHT MONTHS LATER, THIS PATIENT SLIPPED ON A DOCK WHILE CARRYING A BOAT MOTOR AND THIS LEAD BECAME FRACTURED. A REVISION PROCEDURE WAS PERFORMED WHERE THIS LEAD WAS SURGICALLY ABANDONED AND SUCCESSFULLY REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE REVISION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| L| R T167| E110| 0185| 0186| 0184| 4470