BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1951649 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-23733
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    November 26, 2010
    Report Date
    December 13, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    --

    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.

    Description of Event or Problem · 1

    SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION FROM THE LOCAL REPRESENTATIVE THAT THE DEVICE NO LONGER HAS A MONITOR ONLY ZONE AND THE BRADYCARDIA PACING MODE WAS CHANGED TO VVI AT 60 BPM. THE LOCAL REPRESENTATIVE REPORTED THAT THE PATIENT IS NOT PACEMAKER DEPENDENT AND THERAPY EXHAUSTION DID NOT OCCUR IN ANY OF THE EPISODES. NO COMPLICATIONS, INJURY OR PATIENT HARM WAS REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LOCAL REPRESENTATIVE CONTACTED TECHNICAL SERVICES TO REPORT THAT THIS PATIENT WAS ADMITTED TO THE EMERGENCY ROOM (ER). THE PATIENT HAD RECEIVED SHOCK THERAPY DUE TO ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE. IN REVIEW OF THE DEVICE'S ARRHYTHMIA LOGBOOK, IT APPEARS THAT SOME EPISODES WERE NOT AVAILABLE FOR REVIEW. THE RIGHT VENTRICULAR (RV) PACING THRESHOLD WAS 2.6 VOLTS AT 0.5 MS AND THE DEVICE WAS NOT CAPTURING BECAUSE THE RV PACING OUTPUT WAS PROGRAMMED AT 2.4 VOLTS AT 1.0 MS. RV SENSING AND PACING IMPEDANCE WERE WITHIN NORMAL LIMITS. THE PATIENT WAS PLACED ON MEDICATION WHICH RESOLVED THE ATRIAL ARRHYTHMIA. SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LOCAL REPRESENTATIVE REPORTED THAT THE ARRHYTHMIA ASSOCIATED WITH THE TWO MISSING EPISODES HAD BEEN DETECTED IN THE VENTRICULAR TACHYCARDIA (VT) ZONE. THEREFORE, THE EPSIODES WERE NOT PROTECTED BY THE DEVICE'S VENTRICULAR FIBRILLATION (VF) PROTECTION FEATURE. THE DEVICE AND LEAD SYSTEM REMAINS IN-SERVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR E030| 4470| 0185