BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3043208 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-04630
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    December 15, 2012
    Report Date
    January 23, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS CURRENTLY AVAILABLE, 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 SHOCK LEAD IMPEDANCE ON THIS RIGHT VENTRICULAR (RV) LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM EXHIBITED AN ABRUPT INCREASE. IT WAS REPORTED THAT THE SHOCK IMPEDANCE VALUES HAD BEEN STABLE AT 40 TO 50 OHMS, BUT THEN IN MID-DECEMBER INCREASED TO 90 OHMS AND HAD BEEN STABLE AT THAT RANGE SINCE. A SAVE-TO-DISK WAS PERFORMED AND ANALYZED BY BOSTON SCIENTIFIC ENGINEERING AND IT WAS NOTED THAT THE HIGHER IMPEDANCE READINGS WERE ASSOCIATED WITH THE DISTAL COIL OF THE RV LEAD. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) RECOMMENDED COMMANDED SHOCK TESTING AT 1.1 J AND MAXIMUM OUTPUTS, AS WELL AS, DEFIBRILLATION THRESHOLD (DFT) TESTING BE DONE TO ENSURE THERAPY AVAILABILITY. ADDITIONAL INFORMATION WAS RECEIVED THAT COMMANDED AND DFT SHOCK AT 31J WERE NORMAL; IMPEDANCES WERE IN THE 50 OHM RANGE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE PRODUCT REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146669 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0158

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| L| R E110| 1861| 4087| 0158