BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCEPTA

    MDR report key: 3921684 · Received July 9, 2014

    Report

    Report Number
    2124215-2014-11728
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 9, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 VIA THE PATIENT'S REMOTE MONITORING SYSTEM THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) WITH THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED LOW OUT-OF-RANGE (OOR) PACING LEAD IMPEDANCE MEASUREMENTS. ADDITIONAL INFORMATION INDICATES THAT THE PATIENT HAD A VENTRICULAR ASSISTED DEVICE AND WAS BELIEVED TO BE PLAYING A ROLE IN THE OOR IMPEDANCE MEASUREMENTS. THE CAUSE WAS NOT CONCLUSIVELY DETERMINED, HOWEVER WILL CONTINUE TO MONITOR. THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400664 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E160

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR 0295| E160