BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 4131664 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-14062
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    January 1, 2014
    Report Date
    July 15, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM EXHIBITED SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS. THIS WAS DISCOVERED DURING AN IN-OFFICE EVALUATION. NO OTHER OBSERVATIONS WERE REPORTED. THE SHOCKING CONFIGURATION WAS PROGRAMMED TO TRIAD. THE PHYSICIAN DECIDED TO CHANGE THE SHOCK CONFIGURATION TO EXCLUDE THE SVC COIL AND THE SHOCK IMPEDANCE MEASUREMENT WAS THEN AROUND 80 OHMS. THE PATIENT UNDERWENT LEAD INTEGRITY TESTING WITH A 41 JOULE SHOCK AND THE SUBSEQUENT MEASUREMENTS WERE WITHIN NORMAL LIMITS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE WAS LEFT PROGRAMMED IN THE NEW CONFIGURATION. THIS PRODUCT REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613116 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0175

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R 0175| F141