BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIO

    MDR report key: 4132539 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-15150
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    July 7, 2014
    Report Date
    July 8, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOCAL AREA FIELD REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION. AT THIS TIME, NO FURTHER INFORMATION IS AVAILABLE AND RECORDS INDICATE THIS DEVICE REMAINS IN SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS PACEMAKER EXPERIENCED A SYNCOPAL EPISODE. REVIEWED OF AN EPISODE FOUND THE RHYTHM APPEARED TO BE A COMBINATION OF NOISE AND VENTRICULAR TACHYCARDIA (VT). BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THE NOISE COULD BE THE RESULT OF THE PATIENT SEIZING DURING THE EVENT. IT WAS RECOMMENDED TO BRING THE PATIENT IN FOR FURTHER EVALUATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611835 INGENIO IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND K063

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Life Threatening 1270| K063| 4469| 4457