BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3213127 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-10161
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 1, 2013
    Report Date
    January 7, 2015
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS BROUGHT IN TO TEST THE INTEGRITY OF THE SYSTEM. COMMANDED SHOCK TESTING PRODUCED SHOCKING IMPEDANCE MEASUREMENTS OF 48-50 OHMS. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DISCUSSED THE SCENARIO WITH THE CALLER AND SUGGESTED A SAVE TO DISK AND MEMORY DUMP BE PERFORMED TO FURTHER ASSESS THE ISSUE. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION WAS RECEIVED NINETEEN MONTHS AFTER THE INITIAL OBSERVATIONS WERE REPORTED THAT THIS SYSTEM WAS STILL EXHIBITING OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. A BOSTON SCIENTIFIC SALES REPRESENTATIVE STATED THE PHYSICIAN WANTED TO REMAIN CONSERVATIVE AND WILL CONTINUE TO MONITOR THE PATIENT. THIS PRODUCT ISSUE WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE LEAD REMAINS IN SERVICE AND NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A LATITUDE RED ALERT WAS GENERATED FOR THIS LEAD DUE TO AN OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT OF GREATER THAN 200 OHMS. THE PATIENT PERFORMED ISOMETRICS WHICH PRODUCED AN IMPEDANCE VALUE IF 60 OHMS. THE LEAD IS PROGRAMMED TO TRIAD CONFIGURATION AND THE PHYSICIAN PLANS TO CONTINUE TO MONITOR THIS LEAD VIA LATITUDE. 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
    313832 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0186

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Life Threatening E161| 0186| T175