BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3921719 · Received July 9, 2014

    Report

    Report Number
    2124215-2014-11933
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    February 14, 2014
    Report Date
    October 24, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    (B)(4).

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT'S HOME MONITORING EQUIPMENT DETECTED AN OUT OF RANGE HIGH SHOCK LEAD IMPEDANCE FOR THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD SYSTEM. ADDITIONAL INFORMATION RECEIVED THAT SHOCK IMPEDANCE MEASUREMENTS HAD BEEN TRENDING UP; HOWEVER, THE SOURCE WAS NOT IDENTIFIED. THE PATIENT WILL CONTINUE TO BE MONITORED. THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION BECAME AVAILABLE THAT ANOTHER ALERT FOR OUT-OF-RANGE (OOR) HIGH SHOCK IMPEDANCES HAS OCCURRED. ONCE AGAIN, NO INTERVENTION PLANNED AS THIS PATIENT'S IMPEDANCES FLUCTUATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400242 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0292

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR 4135| E142| 0292