BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2913214 · Received January 14, 2013

    Report

    Report Number
    2124215-2013-00283
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 14, 2012
    Report Date
    February 15, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS FURTHER INFORMATION CONCERNING THIS REPORT IS PENDING FURTHER EVALUATION, OUR CURRENT INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    APPROXIMATELY TWO WEEKS LATER, A LEAD REVISION WAS PERFORMED. A NEW RV LEAD AND A NEW DEVICE WERE SUCCESSFULLY IMPLANTED; THE EXISTING RA LEAD WAS REUSED. THE ORIGINAL RV LEAD WAS SURGICALLY ABANDONED BEFORE THE YOKE OF THE IS-1/DF-1 PORTION. THE REMAINING PORTION OF THE LEAD AND ORIGINAL DEVICE WERE COLLECTED AND RETURNED FOR ANALYSIS. X-RAY PERFORMED AT TIME OF EXPLANT NOTED NO ADDITIONAL INTEGRITY CONCERNS WITH THE ORIGINAL RV LEAD (I.E. ABRASION OR FRACTURES). NO ADDITIONAL PATIENT ADVERSE EFFECTS WERE REPORTED. UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, ONLY THE PROXIMAL PORTION OF THE SEVERED LEAD WAS RETURNED. COMPREHENSIVE PHYSICAL AND ELECTRICAL TESTS WERE UNABLE TO BE PERFORMED DUE TO THE RETURNED CONDITION OF THIS LEAD SEGMENT. ELECTRICAL CONTINUITY WAS ABLE TO BE PERFORMED ON THE SINGLE SEGMENT AND PASSED. ANALYSIS WAS UNABLE TO CONFIRM OR REFUTE THE CLINICAL OBSERVATIONS ON THE LEAD SEGMENT RETURNED. FROM SUBJECTIVE EVIDENCE PROVIDED DURING INVESTIGATION, IT MAY BE SPECULATED THAT THE CLINICAL OBSERVATION OF INCONSISTENT AND HIGH IMPEDANCE RESULTS ARE CONSISTENT WITH A BUILDUP OF CALCIFICATION ON THE LEAD'S DISTAL COIL, AND WHEREBY THE PULSE GENERATOR OBSERVES A GRADUAL RISE IN HIGH VOLTAGE IMPEDANCE OVER TIME. HOWEVER, AS THE TIP SEGMENT OF THE LEAD WAS NOT RETURNED TO BOSTON SCIENTIFIC, NO CONFIRMATION OF CALCIFICATION CAN BE MADE.

    Description of Event or Problem · 1

    NEW INFORMATION WAS RECEIVED APPROXIMATELY TWO WEEKS LATER REPORTING SHOCK IMPEDANCE VALUES GREATER THAN >125OHMS IN BOTH SINGLE AND DUAL CONFIGURATIONS DURING ADDITIONAL TROUBLESHOOTING. SHOCK EFFICACY IS QUESTIONABLE, AND VALUES REPORTED AFTER SHOCK DELIVERY AT DIFFERENT STRENGTHS R-WAVE SYNCHRONOUS SHOCK TEST ARE IN DISCREPANCY. MEMORY DOWNLOADS WERE RETURNED TO BOSTON SCIENTIFIC AND ANALYZED BY BOTH ENGINEERING AND TECHNICAL SERVICES. THE RECOMMENDATION BEING THAT THIS LEAD SHOULD BE REVISED AS AN INTEGRITY ISSUE IS SUSPECT AND THE DEVICE CONTINUES TO FUNCTION NORMALLY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE FOLLOW-UP VISIT, THIS HIGH VOLTAGE RIGHT VENTRICULAR (RV) LEAD DISPLAYED RISING SHOCK IMPEDANCE MEASUREMENTS OVER TIME IN THE DUAL COIL. AT TIME OF IMPLANT (2006), THE IMPEDANCE MEASUREMENT WAS 60OHMS. EARLIER THIS YEAR (2012), THE SHOCK IMPEDANCE VALUE WAS 86OHMS, AND TODAY ITS VALUE IS 122OHMS. NO OTHER LEAD MEASUREMENTS ARE OUT OF RANGE (SENSE 20MV, 725OHMS AND A THRESHOLD OF 1.2V @ 0.5). WHEN THE SHOCK VECTOR WAS PROGRAMMED TO SINGLE COIL SETTING, A HIGH-VOLTAGE IMPEDANCE VALUE OF >125OHMS WAS MEASURED. THE PATIENT WILL BE SCHEDULED FOR A RV LEAD REPLACEMENT AS SOON AS POSSIBLE. BOSTON SCIENTIFIC TECHNICAL SERVICES PROVIDED SOME ADDITIONAL TROUBLESHOOTING METHODS TO VERIFY THE INTEGRITY OF THE LEAD, IONIC LAYER PHENOM, OR OVERSENSITIVITY OF THE IMPEDANCE VALUE WITH A RECENT SOFTWARE UPGRADE AND DEVICE COMPATIBILITY. THE CASE IS PENDING FURTHER EVALUATION BY THE PHYSICIAN. NO ADVERSE PATIENT EFFECTS REPORTED. APPROXIMATELY ONE WEEK LATE, THE PATIENT RETURNED TO THE HOSPITAL FOR FURTHER TROUBLESHOOTING. THE LOW VOLTAGE SHOCK IMPEDANCE MEASURED WAS 119OHMS. AFTER SEDATION, AN 5J R-WAVE SYNCHRONOUS SHOCK WAS DELIVERED WITH AN IMPEDANCE OF 59OHMS FOLLOWED BY AN 41J R-WAVE SYNCHRONOUS SHOCK WITH AN IMPEDANCE OF 93 OHMS. THE LOW VOLTAGE SHOCK IMPEDANCE MEASUREMENT THEN DISPLAYED 96OHMS; ALL TESTED IN DUAL COIL CONFIGURATION. THE PATIENT WAS DISCHARGED AND WAS SUBSEQUENTLY FOLLOWED UP TWICE OVER THE NEXT TWO WEEKS. SLIGHT INCREASING SHOCK LEAD IMPEDANCE HAS OCCURRED UP TO 107OHM AS MEASURED TODAY. THERE IS NO FURTHER INTERVENTION PLANNED AND THE PATIENT CONTINUES TO BE MONITORED THROUGH LATITUDE FOR ANY CHANGE IN IMPEDANCE VALUES. NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20069 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0165

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R