BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3921690 · Received July 9, 2014

    Report

    Report Number
    2124215-2014-11884
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    April 9, 2014
    Report Date
    August 5, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENT. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) SUGGESTED MONITORING SINCE PATIENT IS PREGNANT AND ADVISED TO CONDUCT A COMMANDED SHOCK AFTER GIVING BIRTH. THIS SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION INDICATED THAT THIS SYSTEM CONTINUED TO EXHIBIT HIGH SHOCKING IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS. THE PATIENT DELIVERED A BABY RECENTLY AND THE PHYSICIAN PLANNED TO HAVE THE PATIENT VISIT THE OFFICE FOR A CHECK. THIS SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED AN INCREASE IN THE SHOCK IMPEDANCE MEASUREMENTS FROM 79 TO 117 OHMS, WHICH HAD BEEN STABLE FOR THE PAST SEVERAL YEARS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) PROVIDED OPTIONS FOR TROUBLESHOOTING. HOWEVER, NO IMAGING WAS PERFORMED AS THE PATIENT IS PREGNANT AND THE PHYSICIAN HAS ELECTED TO CONTINUE MONITORING. SUBSEQUENT INFORMATION RECEIVED, INDICATED THAT THE SYSTEM EXHIBITED HIGH OUT OUT-OF-RANGE SHOCK IMPEDANCE MEASUREMENTS. A LOCAL FIELD REPRESENTATIVE REPORTED THAT THE PATIENT GAINED A LITTLE WEIGHT DUE TO THE PREGNANCY AND THE PHYSICIAN HAS RESERVED FURTHER IN-CLINIC TESTING AFTER THE PATIENT GIVES BIRTH. THIS SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399733 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 10062 DA E102| 0185