BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCEPTA

    MDR report key: 4132207 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-17069
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    July 11, 2014
    Report Date
    July 20, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SYSTEM REMAINS IMPLANTED AND NO OTHER ADVERSE EVENTS HAVE BEEN REPORTED. THIS PRODUCT ISSUE WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS SYSTEM WAS EXHIBITING INCREASED PACING IMPEDANCE MEASUREMENTS IN THE RIGHT VENTRICULAR (RV) CHANNEL WHICH HAD INCREASED FROM 586 OHMS TO 824 OHMS IN THE PAST TWELVE MONTHS. ISOMETRICS WERE NOT PERFORMED; HOWEVER, THERE WERE NO STORED EPISODES, NO NOISE OR AND NO CHANGE IN SENSING OR THRESHOLD MEASUREMENTS. THE PHYSICIAN DECIDED TO CONTINUE TO FOLLOW THE PATIENT EVERY THREE MONTHS. SIX MONTHS LATER, PACING IMPEDANCE WAS 1300 OHMS. ALL OTHER MEASUREMENTS REMAINED UNCHANGED AND THE PATIENT WILL CONTINUE TO BE MONITORED. DURING A ROUTINE DEVICE REPLACEMENT PROCEDURE OVER TWO YEARS LATER, PACING IMPEDANCE WAS 1900 OHMS WITH THE REPLACEMENT DEVICE. THE LEAD WAS REMOVED FROM THE DEVICE HEADER AND TESTED WITH A PACING SYSTEM ANALYZER (PSA) AND THE MEASUREMENT WAS 1600 OHMS. AFTER RE-INSERTION INTO THE NEW DEVICE, IT WAS AGAIN 1900 OHMS, THEN BEGAN TO DECREASE BUT INCREASED AGAIN TO 1950 OHMS. THE PHYSICIAN DECIDED TO LEAVE THE LEAD IMPLANTED WITH THE REPLACEMENT DEVICE AND CONTINUE TO MONITOR. A SHORT TIME LATER, A RED ALERT WAS RECEIVED FROM THIS SYSTEM DUE TO PACING IMPEDANCE MEASUREMENTS GREATER THAN 2000 OHMS. A LEAD FRACTURE IS SUSPECTED, HOWEVER, NO TESTING WAS PERFORMED TO CONFIRM THIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613085 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E163

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR 0158| 4087| E163| T125