BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2052736 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-04899
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    December 19, 2010
    Report Date
    May 5, 2014
    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).

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE PRODUCT REMAINS IMPLANTED. AT FOLLOW-UP APPOINTMENTS, THE LEAD IMPEDANCE WAS APPROXIMATELY 1600 TO 2000 OHMS. NO INTERVENTION WAS PERFORMED. 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

    --

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECENTLY RECEIVED THAT AN ADDITIONAL FOLLOW-UP WAS PERFORMED TO INVESTIGATE THE ONGOING IMPEDANCE ISSUE. NO ROOT CAUSE WAS FOUND VIA TECHNICAL ANALYSIS, IT HOWEVER IT WAS DETERMINED THAT PACING IMPEDANCES HAVE REMAINED ON AVERAGE AT 1800 OHMS, WITH NUMEROUS VALUES ABOVE 2000 OHMS. NO REMEDIAL ACTION HAS BEEN TAKEN OR PLANNED AT THIS TIME.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THROUGH THE LATITUDE PATIENT MONITORING SYSTEM THAT A RED ALERT WAS DETECTED FOR A RIGHT VENTRICULAR (RV) PACING IMPEDANCE OUT OF RANGE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0175

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR