BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3043113 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-01417
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    July 23, 2012
    Report Date
    October 8, 2013
    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

    AT THIS TIME NO ADDITIONAL INFORMATION IS AVAILABLE WHEN IT COMES TO THE LEAD REVISION PROCEDURE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS INVESTIGATION WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS INVESTIGATION WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION PROVIDED NOTED THAT A LEAD REVISION HAS BEEN SCHEDULED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED NOTED THAT ZERO OHMS WAS DISPLAYED FOR SHOCKING IMPEDANCES AND AN INQUIRY WAS MADE AS TO WHY THIS VALUES WAS ZERO. TECHNICAL SERVICES DISCUSSED THAT WITH THE CORRECT SOFTWARE A DISPLAY OF ZERO OHMS INDICATES THAT THE SHOCK IMPEDANCES ARE < 20 OHMS. TECHNICAL SERVICES DISCUSSED THAT THIS IS LIKELY DUE TO ELECTROMAGNATIC INTERFERENCE AS OTEHR VALUES ARE STABLE AND WITHIN RANGE. A COMMANDED SHOCK TEST WAS ALSO DISCUSSED. AT THIS TIME THE SYSTEM REMAINS IMPLANTED.

    Description of Event or Problem · 1

    -

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD DISPLAYED HIGH OUT OF RANGE PACING IMPEDANCES. LATITUDE CUSTOMER SUPPORT (LCS) WAS CONTACT TO DISCUSS OUT OF RANGE IMPEDANCES. IT WAS NOTED THAT THE PATIENT WAS SEEN SEVERAL TIMES FOR PROVOCATION MANEUVERS AND NO NOISE WAS NOTED. TECHNICAL SERVICES DISCUSSED THAT THIS LEAD HAS BEEN IMPLANTED SINCE 2005, AND WAS IMPLANTED WITH THE NEW DEVICE IN 2010 THUS POSSIBLE LEAD ISSUE COULD BE PRESENT. IT WAS NOTED THAT THE SHOCK IMPEDANCES REMAIN STABLE. IN ADDITION, TECHNICAL SERVICES DISCUSSED MONITORING THE PATIENT TO SEE IF OCCURRENCE OF THE OUT OF RANGE IMPEDANCES INCREASE OVER MONTHS, AND IF SO A LEAD REVISION SHOULD BE CONSIDERED. AT THIS TIME THE RIGHT VENTRICULAR LEAD REMAINS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146172 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0158

    Patients

    Seq Age Sex Outcome Treatment
    1