BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIO

    MDR report key: 4132165 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-15312
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    July 24, 2014
    Report Date
    July 24, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    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 CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRT-P) PRESENTED FOR ROUTINE FOLLOW-UP. WHILE IN CLINIC THE PATIENT EXPERIENCED A SYNCOPAL EPISODE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612294 INGENIO IMPLANTABLE CHF GENERATOR LWP GUIDANT CRM CLONMEL IRELAND V172

    Patients

    Seq Age Sex Outcome Treatment
    1 97 YR Life Threatening H135| H215| 0158| V172| MISMATCH| 4513| 1388TC