BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3904868 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-10726
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    April 20, 2014
    Report Date
    April 23, 2015
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073
    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 SYSTEM IS CONTINUING TO EXHIBIT MULTIPLE HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS OF GREATER THAN 125 OHMS. ADDITIONAL INFORMATION PROVIDED FROM THE FIELD INDICATED THAT NO FURTHER ACTION WILL BE TAKEN AND THE PATIENT WILL CONTINUE TO BE MONITORED. ALL PRODUCTS CONTINUE TO REMAIN IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    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 EXHIBITED A HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT OF GREATER THAN 125 OHMS. ADDITIONAL INFORMATION PROVIDED FROM THE FIELD INDICATED THAT THE PATIENT WILL CONTINUE TO BE MONITORED. THE SYSTEM CONTINUES TO REMAIN IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384985 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR MISMATCH| H177| N107| 4470| 0184