BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 4884623 · Received July 1, 2015

    Report

    Report Number
    2124215-2015-07729
    Event Type
    Malfunction
    Date Received
    July 1, 2015
    Date of Event
    June 1, 2015
    Report Date
    June 2, 2015
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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.

    Description of Event or Problem · 1

    SCIENTIFIC RECEIVED INFORMATION THAT THIS DEVICE AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED A HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) REVIEWED THE AVAILABLE INFORMATION AND INDICATED THE SHOCK IMPEDANCE MEASUREMENTS HAVE BEEN STABLE FOR THE LAST YEAR AROUND 70 TO 80 OHMS WHICH IS NORMAL FOR A SINGLE COIL LEAD. THERE WAS ONLY THE SINGLE HIGH READING AND THERE HAVE BEEN NO NEW READINGS SINCE THE RED ALERT WAS TRIGGERED. THE PRESENTING ELECTROGRAM SHOWED NORMAL DEVICE OPERATION AND NO NOISE WAS NOTED. THIS DEVICE HAS NEVER DELIVERED A SHOCK SO THERE ARE NO RECORDED MEASUREMENTS OF DELIVERED SHOCK IMPEDANCE. X-RAY REVEALED NO ABNORMALITIES. IT WAS INDICATED THE PATIENT WOULD CONTINUE TO BE FOLLOWED APPROPRIATELY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426770 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0138

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR F161| 0138