BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2062478 · Received April 19, 2011

    Report

    Report Number
    2124215-2011-06836
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 22, 2011
    Report Date
    April 20, 2016
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED TWENTY ONE MONTHS FOLLOWING THE INITIAL CLINICAL OBSERVATIONS STATING THAT THE RED ALERTS ARE STILL BEING PRODUCED DUE TO HIGH SHOCK IMPEDANCE MEASUREMENTS. THE INFORMATION HAS BEEN COMMUNICATED TO THIS PATIENT'S PHYSICIAN. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE RED ALERTS ARE STILL BEING PRODUCED DUE TO HIGH SHOCK IMPEDANCE MEASUREMENTS. A REVIEW OF THE DATA SHOWED THE MEASUREMENTS HAVE RANGED FROM 80 OHMS TO 138 OHMS OVER THE PAST YEAR. THE BOSTON SCIENTIFIC SALES REPRESENTATIVE STATED THAT NO TESTING WAS PERFORMED TO IDENTIFY THE CAUSE OF THE OUT OF RANGE MEASUREMENTS AND THE PATIENT WILL CONTINUE TO BE FOLLOWED. 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

    ADDITIONAL INFORMATION WAS RECEIVED THIRTEEN MONTHS LATER STATING THAT THE RED ALERTS ARE STILL BEING PRODUCED DUE TO HIGH SHOCK IMPEDANCE MEASUREMENTS. THE INFORMATION HAS BEEN COMMUNICATED TO THIS PATIENT'S PHYSICIAN. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A RED ALERT WAS RECEIVED STATING A HIGH SHOCK IMPEDANCE MEASUREMENT HAD BEEN DETECTED FROM THIS SYSTEM. THE PATIENT WAS GOING TO BE SEEN FOR AN EVALUATION; HOWEVER, SHE DID NOT SHOW UP FOR THE FOLLOW UP VISIT. NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR (B)(4)| (B)(4)