BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INCEPTA

    MDR report key: 3905414 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-10071
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    April 24, 2014
    Report Date
    April 29, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO ADDITIONAL INFORMATION IS CURRENTLY AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT STATED SHE EXPERIENCED SYNCOPE FOR AN UNKNOWN REASON. THE PATIENT DID NOTE THAT HER MEDICATION HAS CHANGED WITHIN THE LAST TWO WEEKS. SHE HAD ALREADY NOTIFIED HER CLINIC REGARDING THIS ISSUE. BOSTON SCIENTIFIC PATIENT SERVICES REFERRED THE PATIENT BACK TO HER PHYSICIAN'S OFFICE FOR FOLLOW-UP. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382388 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWP GUIDANT CRM CLONMEL IRELAND E162

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening E162| 4135| 0295