BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3053355 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05667
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 10, 2013
    Report Date
    April 10, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTH CARE PROFESSIONAL (HCP) THAT ALL SUBSEQUENT SHOCK IMPEDANCE MEASUREMENTS REMAIN WITHIN NORMAL LIMITS WITH NO ADDITIONAL OUT OF RANGE MEASUREMENTS. THE PHYSICIAN WILL CONTINUE MONITORING. 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

    THE LOCAL AREA SALES REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND IMPLANTABLE DEFIBRILLATION LEAD EXHIBITED A HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT GREATER THAN 125 OHMS. REVIEW OF STORED DEVICE MEMORY REVEALED THAT SHOCK IMPEDANCE MEASUREMENTS HAD VARIED BETWEEN 80-110 OHMS, HOWEVER, ALL OTHER LEAD MEASUREMENTS WERE WITHIN NORMAL LIMITS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED TROUBLESHOOTING OPTIONS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155845 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0180

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR 4135| 0180| E110