BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2914322 · Received January 14, 2013

    Report

    Report Number
    2124215-2013-00726
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 14, 2012
    Report Date
    December 14, 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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT'S CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND RIGHT VENTRICULAR (RV) LEAD SYSTEM IS EXHIBITING HIGH, OUT-OF-RANGE (OOR), SHOCK LEAD IMPEDANCE READINGS IN BOTH DAILY MEASUREMENTS AND COMMANDED TESTING. IIN CLINIC TESTING WAS DONE AND THE DEVICE WAS EVALUATED WITH VARIOUS SHOCK VECTORS. THE RV COIL TO CAN CONFIGURATION YIELDED A MEASUREMENT OF 106 OHMS AND RV COIL TO RA COIL WAS 100 OHMS. THE SHOCK VECTOR WAS CHANGED TO THE RV COIL TO CAN CONFIGURATION AND AN X-RAY WAS GOING TO BE DONE. FURTHER INFORMATION WAS RECEIVED FROM THE FIELD REPRESENTATIVE THAT NOTHING ADDITIONAL WAS CHANGED AND THAT THE PATIENT WOULD CONTINUE TO BE MONITORED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20475 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Life Threatening| R 4058| 4549| 4004| H210| N141| 0184| 4054