BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3212998 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09311
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 3, 2011
    Report Date
    October 8, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION IS AVAILABLE. ONCE ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THSI REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE DEVICE WAS THOROUGHLY ANALYZED. A VISUAL INSPECTION OF THE DEVICE NOTED NO ARC MARKS ON THE TITANIUM CASE. REVIEW OF THE STORED MEMORY CONFIRMED A SHORTED LEAD INDICATOR WAS RECORDED BY THE DEVICE ON (B)(6) 2013. A BENCH TEST TO ASSESS THE OUTPUT BRIDGE INTEGRITY WAS PERFORMED AND A LOW SHOCK IMPEDANCE MEASUREMENT RESULTED. THIS OUT-OF-RANGE MEASUREMENT INDICATES THE HIGH ENERGY OUTPUT BRIDGE IS ELECTRICALLY DAMAGED. NO FURTHER TESTING WAS PERFORMED AS THIS TYPE OF DAMAGE, CONSISTENT WITH AN ATTEMPT TO DELIVER THERAPY THROUGH A SHORTED LEAD SYSTEM, IS KNOWN TO CAUSE INTERNAL DAMAGE TO THE CIRCUITRY. LABORATORY ANALYSIS CONFIRMED THAT THE CLINICAL OBSERVATIONS WERE A RESULT OF THE DEVICE BEING DAMAGED FROM THE RV LEAD SHORTING TO THE DEVICE OUTPUT BRIDGE WHEN DELIVERING A SHOCK WHILE IMPLANTED.

    Additional Manufacturer Narrative · 1

    ONCE ANY ADDITIONAL INFORMATION DOES BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

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    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS REPORTED THAT DURING TESTING OF THE SYSTEM, THE FIRST SHOCK OF 1.1 JOULES DISPLAYED A SHOCK LEAD IMPEDANCE MEASUREMENT OF BELOW 20 OHMS. AFTER THE SECOND 31 JOULE SHOCK WAS DELIVERED, THE DEVICE DISPLAYED THE ALERT FOR A SHORTED LEAD CONDITION AND THE DEVICE COULD NO LONGER SENSE OR PACE. IN ADDITION, ALL LEADS HAD A PACING IMPEDANCE MEASUREMENT OF BELOW 200 OHMS. IT WAS SUSPECTED THAT THE LOW OUT OF RANGE IMPEDANCES ON THE RIGHT ATRIAL (RA) AND LEFT VENTRICULAR (LV) LEADS WERE DUE TO THE DAMAGED DEVICE. A REVISION WAS PERFORMED AND BOTH THE RA AND LV LEADS WERE TESTED. BOTH LEADS HAD ELECTRICAL PARAMETERS IN NORMAL RANGE. THE RV LEAD AND DEVICE WERE SUCCESSFULLY REPLACED. THE RA AND LV LEADS REMAIN IMPLANTED WITH THE NEW DEVICE. THE RV LEAD WAS CAPPED AND SURGICALLY ABANDONED AND THE EXPLANTED DEVICE WAS RETURNED FOR LABORATORY ANALYSIS. . NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    A TS CONSULTANT REVIEWED THE DATA AND CONFIRMED THAT BOTH THE PACING IMPEDANCE MEASUREMENTS HAVE REMAINED STABLE AROUND 250 OHMS AND THERE WERE TWO OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS WITH ONE OF THOSE BEING BELOW 20 OHMS. THE TS CONSULTANT DISCUSSED TROUBLESHOOTING THAT COULD BE PERFORMED TO HELP DETERMINE THE CAUSE OF THE MEASUREMENT CHANGE AND TEST THE INTEGRITY OF THE SYSTEM. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT AT A NORMAL PATIENT FOLLOW UP, IT WAS NOTED THAT THE PACING IMPEDANCE MEASUREMENTS ON THIS RIGHT VENTRICULAR (RV) LEAD WERE DECREASING TO BETWEEN 265 TO 400 OHMS. THE AMPLITUDES WERE ALSO DECREASING. NO ADVERSE PATIENT EFFECTS WERE REPORTED AND THIS PATIENT IS NOT PACEMAKER DEPENDENT. THE PATIENT WAS CONTINUED TO BE MONITORED NORMALLY. SEVERAL YEARS LATER, IT WAS NOTED DURING A NORMAL FOLLOW UP THAT THERE WERE TWO SHOCK IMPEDANCE MEASUREMENTS BELOW 20 OHMS IN THE DAILY MEASUREMENTS. ALL OTHER LEAD MEASUREMENTS WERE STABLE AND THE SHOCK IMPEDANCE MEASUREMENT DURING TESTING WAS 42 OHMS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE PATIENT WILL BE SEEN AGAIN DURING THE NEXT THREE MONTH FOLLOW UP. A MEMORY DOWNLOAD WAS SENT TO BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) FOR FURTHER EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313910 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0148

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| O