BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2911763 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16812
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    December 1, 2012
    Report Date
    October 8, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WILL BE RETURNED FOR FINAL ANALYSIS. PRELIMINARY ANALYSIS OF THE PROVIDED SAVE TO DISK DATA SHOWS THAT A SHORT CIRCUIT CONDITION OCCURRED DURING SHOCK DELIVERY AND DAMAGED THE DEVICE CAUSING CHARGE TIME-OUTS. THE DEVICE EXITED STORAGE MODE AND WAS INITIALLY IN "TACHY OFF" MODE. THE TACHY MODE WAS THEN CHANGED TO "MONITOR PLUS THERAPY" AND A SHORT CIRCUIT CONDITION WAS DETECTED DURING SHOCK DELIVERY, TRIGGERING A FAULT CODE. THIS RESULTS FROM A SHOCK INTO A LOW LEAD IMPEDANCE AND REDETECTION WOULD BE INITIATED, HOWEVER, SUBSEQUENT CAPACITOR CHARGE TIMES EXCEEDED THE TIME-OUT LIMIT, INITIATING A SECOND FAULT CODE. FURTHER ANALYSIS OF DEVICE HARDWARE WILL BE PERFORMED WHEN THE LEAD IS RETURNED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. VISUAL OBSERVATIONS NOTED ARC MARKS ON THE DISTAL SHOCKING COIL. THIS IS CONSISTENT WITH INDUCED DAMAGE DUE A ELECTRICAL SHOCK BEING DELIVERED BY THE DEVICE INTO A SHORTED LEAD. RESISTANCE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING AN IMPLANT PROCEDURE, AFTER SUCCESSFULLY IMPLANTING ALL THE LEADS DURING POCKET CLOSURE, THE PATIENT WENT INTO SUPRAVENTRICULAR TACHYCARDIA. UPON INTERROGATING THE DEVICE, IT WAS NOTED THE PATIENT WAS IN ATRIAL FLUTTER, HOWEVER THE PATIENT EVENTUALLY WENT INTO VENTRICULAR TACHYCARDIA. THERAPY WAS PROGRAMMED ON, AND THE PATIENT RECEIVED ANTI TACHY PACING AND SHOCK THERAPY, HOWEVER, THE RHYTHM PERSISTED. THE PHYSICIAN REQUESTED THERAPY TO BE PROGRAMMED BACK OFF, HOWEVER IT WAS NOW NOTED THE DEVICE COULD NOT BE INTERROGATED OR PROGRAMMED. THE PHYSICIAN ELECTED TO EXPLANT THE ENTIRE SYSTEM AT THIS TIME. UPON INTERROGATING THE DEVICE AFTER THE PROCEDURE, A MESSAGE THAT "A SHORT CIRCUIT CONDITION WAS DETECTED DURING SHOCK DELIVERY" WAS NOTED. ADDITIONALLY, THE BATTERY WAS OBSERVED TO BE AT END OF LIFE (END OF LIFE (EOL). NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18686 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1