BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3210044 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07382
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 17, 2013
    Report Date
    October 8, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ICD PRODUCT WAS RETURNED FOR ANALYSIS; THE LEAD WAS SURGICALLY ABANDONED. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ICD ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. PIN GAUGE TESTING, DESIGNED TO VERIFY PROPER PORT DIMENSIONS, WAS COMPLETED. EACH PORT MEASURED AS EXPECTED. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY WITH NO INTERRUPTIONS IN THERAPY OUTPUT AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. LABORATORY ANALYSIS DID NOT IDENTIFY ANY DEVICE CHARACTERISTICS THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CLINICAL OBSERVATIONS.

    Additional Manufacturer Narrative · 1

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    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED IN THE NEAR FUTURE, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

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    Description of Event or Problem · 1

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    Description of Event or Problem · 1

    APPROXIMATELY ONE MONTH LATER, THE PATIENT RETURNED FOR EVALUATION AND REVISION. NOISE WAS REPRODUCIBLE BEFORE AND DURING THE PROCEDURE WITH MANEUVERS WHILE CONFIRMING CONNECTIONS. NO NOTICEABLE LEAD DAMAGE WAS OBSERVED. X-RAY ANALYSIS REVEALED INSERTION ISSUES WITH THIS LEAD'S TERMINAL PINS. THE PHYSICIAN ELECTED TO REPLACE THE ICD AND SURGICALLY ABANDONED THE LEAD. A NEW NON-BOSTON SCIENTIFIC DEVICE AND BOSTON SCIENTIFIC LEAD COMBINATION WAS SUCCESSFULLY IMPLANTED. THE ICD WAS FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OCCURRED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT RECENT NOISE EPISODES STORED ON THIS PATIENT SYSTEM ARE MOST LIKELY RELATED TO A LEAD CONNECTION OR LEAD INTEGRITY ISSUE. ADDITIONALLY, THE PATIENT RECEIVED INAPPROPRIATE SHOCKS AS A RESULT OF RHYTHM ID DEFAULT. MUCH INVESTIGATION HAS PURSUED THE PAST WEEK WITH BOSTON SCIENTIFIC TECHNICAL THERAPY SUPPORT (TTS) EVALUATING PRINTOUTS AND DATA DISK ANALYSIS OF STORED EPISODES. IT IS UNDERSTOOD THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (F102; ICD) AND THE RIGHT VENTRICULAR (0181; RV) LEAD WERE IMPLANTED ABOUT TWO YEARS AGO. APPROXIMATELY TWO MONTHS POST-IMPLANT, NOISE WAS RECORDED ON THE SHOCK CHANNEL, AS EVIDENT BY REVIEW OF HISTORICAL EPISODES. TTS CONFIRMED THAT THE RECORDED NOISE IS CONSISTENT WITH A LEAD OR WITH A CONNECTION ISSUE. THE NOISE IS LOW FREQUENCY, RANDOMLY DISTRIBUTED WITH HIGH AMPLITUDE. ADDITIONALLY, FROM TREND HISTORICAL TREND GRAPH REVIEW, BOTH THE RV AND SHOCK IMPEDANCES FLUCTUATE BUT THE GENERAL TREND IS QUITE STABLE WITH A DECREASE BEGINNING EARLIER THIS MONTH. ADDITIONAL TROUBLESHOOTING WAS PERFORMED CLINICALLY, AND THE NOISE WAS REPRODUCIBLE WITH ARM STRETCHING AND OTHER RELATED MANOEUVRES. TTS RECOMMENDED AN INTENSIVE INVESTIGATION ON THIS LEAD, AND A SYSTEM INTEGRITY TEST TO DETERMINE THE ROOT CAUSE OF THIS ISSUE. THE PHYSICIAN PLANS TO SEE THE PATIENT IN SHORTENED INTERVALS, AS WELL AS TO PROVIDE REMOTE MONITORING. THERE HAVE BEEN NO ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310099 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0181

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R