BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCEPTA

    MDR report key: 3904806 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-11083
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    April 28, 2014
    Report Date
    April 28, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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 THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EMITTED BEEPING TONES. UPON THE PATIENT'S PRESENTATION FOR FOLLOW-UP IT WAS DISCOVERED THAT A SINGLE HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT GREATER THAN 125 OHMS WAS RECORDED TO THE DEVICE. UPON FURTHER REVIEW, SHOCK IMPEDANCE MEASUREMENTS APPEARED TO BE TRENDING HIGHER OVER PRECEDING MONTHS. ALL OTHER LEAD PARAMETERS WERE NOTED TO BE STABLE AND WITHIN NORMAL LIMITS. POCKET MANIPULATIONS WERE PERFORMED WITH THE PATIENT IN DIFFERENT POSITIONS AND SHOCK IMPEDANCES WERE NOTED TO VARY 10-20 OHMS WHICH THE PHYSICIAN CONSIDERED NORMAL. NO COMMANDED SHOCKS WERE PERFORMED AND THERE WAS NO SUSPICION OF PHYSICAL LEAD DAMAGE. THE PATIENT WILL BE SEEN FOR FOLLOW UP IN THREE MONTHS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS SYSTEM REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383083 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F162

    Patients

    Seq Age Sex Outcome Treatment
    1 F162| 0292| 4470