BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK ENDURANCE EZ

    MDR report key: 2910005 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15237
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 6, 2012
    Report Date
    April 2, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    PMA / PMN Number
    P910073/S026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION, THIS LEAD REMAINS IMPLANTED AND IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT A DEVICE REPLACEMENT PROCEDURE WAS PERFORMED. PRIOR TO THE PROCEDURE, THIS RIGHT VENTRICULAR LEAD DISPLAYED NORMAL MEASUREMENTS. WHEN THIS CHRONIC LEAD WAS CONNECTED TO THE REPLACEMENT DEVICE, HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS WERE OBSERVED. THE LEAD WAS DISCONNECTED AND RESEATED IN THE PREVIOUS DEVICE (T175). NORMAL SHOCK IMPEDANCE MEASUREMENTS WERE OBTAINED. THEN THE LEAD WAS RECONNECTED TO THE REPLACEMENT DEVICE (F051) AND HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS WERE AGAIN OBSERVED. MEASUREMENTS IN THE DISTAL COIL WERE WITHIN NORMAL RANGE. IT WAS THOUGHT THE POSITIVE PIN OF THE PROXIMAL COIL WAS DAMAGED AND CONTRIBUTED TO THE OUT OF RANGE MEASUREMENT. THE DEVICE REMAINED PROGRAMMED WITH THE SHOCK VECTOR DISTAL COIL TO CAN AND THE LEAD MEASUREMENTS WERE NORMAL. AN INTERNAL TECHNICAL SERVICE CONSULTANT WAS CONTACTED FOR THEIR RECOMMENDATIONS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. TECHNICAL SERVICES DETERMINED THAT THIS OUT OF RANGE MEASUREMENT MAY INDICATE A LEAD ISSUE AND RECOMMENDED FURTHER TROUBLESHOOTING MEASURES. IN ADDITION, IT WAS THOUGHT THAT THIS MAY HAVE BEEN DUE TO EXTERNAL INTERFERENCE. AT THIS TIME, THE LEAD REMAINS IMPLANTED AS PROGRAMMED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS OBTAINED. FURTHER HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS HAVE BEEN OBSERVED. A DECISION WAS MADE TO REPLACE THIS LEAD IN THE NEAR FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16840 ENDOTAK ENDURANCE EZ IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION 0154 343237
    16875 ENDOTAK ENDURANCE EZ IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION 0154 343237

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown