BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIO

    MDR report key: 4131690 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-15086
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    July 4, 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
    PATIENT FAMILY MEMBER OR FRIEND

    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 PATIENTS DAUGHTER CALLED PATIENT SERVICES (PS) AND STATED THAT THE PATIENT HAD RECENTLY PASSED OUT AND WANTED TO ENSURE THAT THE DEVICE IS WORKING. THE REASON FOR THE SYNCOPAL EPISODE IS UNKNOWN AND NOT SURE IF ITS DEVICE RELATED OR NOT. PS SUGGESTED CONTACTING THE PATIENT'S PHYSICIAN AND SPEAKING TO THEM REGARDING THE SYNCOPE. TO DATE, NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612612 INGENIO IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND K063

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Life Threatening K063| 4135| 4136