BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2911809 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16476
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 7, 2012
    Report Date
    December 7, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    PHYSICIAN

    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 THE PATIENT WITH THIS RIGHT VENTRICULAR (RV) LEAD WAS UNDERGOING A NORMAL GENERATOR CHANGEOUT PROCEDURE. THE PATIENT HAD COMPLETE HEART BLOCK, THEREFORE, THE GENERATOR WAS PROGRAMMED TO PACE IN THE VENTRICLES ONLY (ELECTROCAUTERY MODE) DURING THE PROCEDURE. THE PATIENT'S LEFT VENTRICULAR (LV) LEAD WAS REMOVED FROM THE HEADER AND THE PATIENT WENT ASYSTOLE. THE LV LEAD WAS HOOKED UP TO THE PACING SYSTEM ANALYZER (PSA). THIS RV LEAD HAD PULLED OUT OF THE HEADER WITHOUT THE SETSCREWS BEING UNSCREWED. ONE OF THE RV SETSCREWS WAS BELIEVED TO BE STRIPPED AND STUCK; THEREFORE, PACING WAS LOST WHEN NOT EXPECTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LEAD REMAINS IN-SERVICE WITH THE PATIENT'S NEW GENERATOR AND NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17797 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR 0185| 4064| 4548| 1283| 4554| 4035| H210