BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3905401 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-11580
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    June 1, 2013
    Report Date
    October 7, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY THE ENTIRE LEAD WAS RETURNED IN TWO SEGMENTS SEVERED 18 CM FROM THE IS-1 TERMINAL PIN. THE EXTRACTING STYLET REMAINED STUCK WITHIN THE DISTAL LEAD SEGMENT AND SETSCREW MARKS WERE NOTED ON ALL TERMINAL CONNECTORS. CALCIFIED BODY FLUID WAS OBSERVED ON PORTIONS OF BOTH THE DISTAL AND PROXIMAL SHOCKING COILS. CONTINUITY TESTS WERE ALSO PERFORMED WHICH THE LEAD PASSED. LABORATORY ANALYSIS COULD NOT CONFIRM THE REPORTED CLINICAL OBSERVATION OF HIGH OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENTS. HOWEVER, CALCIFICATION ON THE LEAD COULD AFFECT IMPEDANCE MEASUREMENTS.

    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). THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCES DISCOVERED DURING ROUTINE FOLLOW UP THOUGH MEASURING 90 OHMS THAT DAY. UPON REVIEW OF DATA STORED TO THE ICD, BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) NOTED THAT SHOCK IMPEDANCES FIRST MEASURED OUTSIDE OF NORMAL LIMITS APPROXIMATELY 1 YEAR PRIOR TO THE PATIENT'S MOST RECENT FOLLOW UP. FROM THAT TIME ON SHOCK IMPEDANCES WERE NOTED TO VARY CONSIDERABLY BETWEEN NORMAL AND HIGH OUT OF RANGE VALUES. NO EPISODES OF NOISE WERE FOUND STORED TO THE DEVICE OUTSIDE OF A SINGLE INCIDENT DUE TO AN UNRELATED SURGERY ON THE PATIENT'S SHOULDER PRIOR TO THE OUT OF RANGE MEASUREMENTS. TS SUGGESTED STEPS FOR ASSESSING INTEGRITY OF THE RV LEAD INCLUDING DELIVERY OF A 1.1 J SYNCHRONIZED SHOCK. THE ICD WAS PROGRAMMED TO EMIT TONES IN THE EVENT OF AN OUT OF RANGE SHOCK IMPEDANCE AND THE SHOCK VECTOR REPROGRAMMED TO A SHOCK COIL TO DEVICE CONFIGURATION. INFORMATION WAS LATER RECEIVED INDICATING THE PATIENT PRESENTED FOR ADDITIONAL FOLLOW-UP WHERE CONTINUOUS IMPEDANCE MEASUREMENTS WERE TAKEN DURING PROVOCATION TESTING. ADDITIONALLY, A 2J COMMANDED SHOCK WAS PERFORMED WITH A SHOCK IMPEDANCE OF 65 OHMS. ALL MEASUREMENTS WERE NOTED TO BE WITHIN NORMAL LIMITS SINCE THE SHOCK CONFIGURATION WAS REPROGRAMMED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS SYSTEM REMAINS IN SERVICE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS LATER RECEIVED INDICATING THE PATIENT PRESENTED TO THE HOSPITAL DUE TO THE DEVICE EMITTING TONES. UPON INTERROGATION IT WAS FOUND THAT THE ICD AND RV LEAD CONTINUED TO EXHIBIT HIGH OUT OF RANGE SHOCK IMPEDANCES DESPITE THE DEVICE BEING REPROGRAMMED SEVERAL WEEKS EARLIER. A REVISION PROCEDURE WAS PERFORMED WHEREIN THE RV LEAD WAS EXPLANTED AND REPLACED. MEASUREMENTS FOR THE REPLACEMENT LEAD WERE WITHIN EXPECTED RANGE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS RV LEAD IS NO LONGER IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382326 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0174

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R 0174| F102| T175