BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2911729 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16302
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 5, 2012
    Report Date
    December 10, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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.

    Additional Manufacturer Narrative · 1

    WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED: A REVISION PROCEDURE WAS PERFORMED. AFTER THE POCKET WAS REOPENED, VISUAL INSPECTION REVEALED THE HIGH VOLTAGE LEAD CONNECTIONS WERE REVERSED IN THE DEVICE HEADER. THE CONNECTIONS WERE CORRECTLY SECURED INTO THE DEVICE HEADER. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT POST IMPLANT PROCEDURE, A REVIEW OF THE ELECTROGRAM REVEALED DIFFERENT GAIN SETTINGS AND LOW AMPLITUDE IN ADDITION TO HIGH P WAVES. IT WAS SUSPECTED THIS WAS THE RESULT OF THIS RIGHT VENTRICULAR HIGH VOLTAGE LEAD CONNECTIONS REVERSED IN THE HEADER. AN INTERNAL TECHNICAL SERVICE CONSULTANT WAS CONTACTED. TROUBLESHOOTING RECOMMENDATIONS WERE PROVIDED, HOWEVER REVERSED CONNECTION OF DF-/+ WAS SUSPECTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16765 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0175

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R