BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3921988 · Received July 9, 2014

    Report

    Report Number
    2124215-2014-13355
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 2, 2014
    Report Date
    March 17, 2016
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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). ALL AVAILABLE INFORMATION INDICATES THAT THE SYSTEM REMAINS IN SERVICE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW OUT-OF-RANGE (OOR) SHOCKING LEAD IMPEDANCE MEASUREMENTS. ADDITIONAL INFORMATION WAS UNABLE TO BE OBTAINED. AT THIS TIME THERE IS NO EVIDENCE THAT INTERVENTION HAS BEEN PERFORMED TO RESOLVE THIS ISSUE. THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT DIED APPROXIMATELY NINE MONTHS LATER. THERE HAVE BEEN NO ADDITIONAL ALLEGATIONS OR COMPLAINTS SINCE THE ALERT OCCURRED FOR LOW SHOCK IMPEDANCES IN (B)(6) 2014. AN ONLINE OBITUARY STATED THE PATIENT DIED AT A LOCAL HOSPITAL. NO DETAILS ABOUT THE PATIENT'S DEATH WERE AVAILABLE. THE FIELD REPRESENTATIVE REVIEWED THE PATIENT'S MEDICAL RECORDS AT THE CLINIC AND NOTED THAT ON (B)(6) 2015 THE SHOCK IMPEDANCE MEASUREMENTS WERE 54 OHMS, WHICH IS CONSIDERED NORMAL RANGE. A REVIEW OF REMOTE MONITORING DATA INDICATED THAT THE PATIENT RECEIVED SUCCESSFUL SHOCK THERAPY ON (B)(6) 2015 FOR A TRUE VENTRICULAR ARRHYTHMIA. IN SOME EPISODES ANTI-TACHYCARDIA PACING (ATP) WAS DELIVERED AND UNSUCCESSFUL, BUT ALL SHOCKS DELIVERED WERE SUCCESSFUL IN CONVERTING THE ARRHYTHMIA. SHOCK IMPEDANCES DURING THAT TIME WERE NORMAL BETWEEN 40-70 OHMS. THE DOCUMENTED CAUSE OF DEATH WAS A MYOCARDIAL INFARCTION AND THE FIELD REPRESENTATIVE CONFIRMED THAT THE PHYSICIAN AND THE OTHER CLINIC STAFF WERE NOT CONCERNED WITH A SYSTEM INTEGRITY ISSUE AND SUSPECT THE LOW SHOCK IMPEDANCE FROM 2014 MAY HAVE BEEN A ONE-TIME OCCURRENCE. THE FIELD REPRESENTATIVE WAS NOT AWARE IF THE SYSTEM WAS EXPLANTED POST-MORTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401543 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0157

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR 1853| E110| 4469