BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2910906 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16402
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 19, 2012
    Report Date
    March 20, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    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 A ROUTINE DEVICE INTERROGATION ONE WEEK POST IMPLANT, THE FIELD REPRESENTATIVE NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT WHEN PROGRAMMED IN A TRIAD CONFIGURATION. THE DEVICE WAS PROGRAMMED WITH THE SHOCK CONFIGURATION TO RV TO CAN FROM TRIAD. THREE DAYS LATER THE REMOTE HOME MONITORING SYSTEM ISSUED AN ALERT FOR ANOTHER HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT. SUBSEQUENTLY A REVISION PROCEDURE WAS PERFORMED WHERE THE RV LEAD WAS SURGICALLY ABANDONED AND A NEW LEAD WAS SUCCESSFULLY IMPLANTED WITH THE EXISTING DEVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT REPORTS THAT A LEAD WAS BROKEN AND RESULTED IN SURGICAL INTERVENTION WHERE ANOTHER LEAD WAS IMPLANTED. THE PATIENT REPORTED ARM SWELLING AND SORENESS BECAUSE OF THE ADDITION OF THE LEAD, AND THAT RINGS NEEDED TO BE MADE BIGGER. ADDITIONAL INFORMATION WAS REQUESTED FROM THE FIELD RELATED TO LEAD DAMAGE, BUT NOTHING FURTHER WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17479 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| L| R 4543| H210| N141| 4470| 0184| T177