BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCEPTA

    MDR report key: 2042256 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01399
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    January 18, 2011
    Report Date
    January 18, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN ELECTED TO LEAVE THE SYSTEM IMPLANTED WITH NO CHANGES. 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 THAT, DURING A ROUTINE DEVICE REPLACEMENT PROCEDURE, THIS DEVICE HAD RECORDED A PACING IMPEDANCE MEASUREMENT GREATER THAN 2,000 OHMS. THE ASSOCIATED LEAD HAD NORMAL MEASUREMENTS AS MEASURED BY THE PREVIOUS DEVICE AND A PACING SYSTEM ANALYZER. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F161

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR F161| 1860| 0128