BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 4132308 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-15836
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    July 15, 2014
    Report Date
    July 19, 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). 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 PATIENT EXPERIENCED TWO SYNCOPAL EVENTS FOR UNKNOWN REASONS. OUR BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DEPARTMENT RECEIVED A CALL FROM A HEALTH CARE PROFESSIONAL (HCP) ASKING THAT WE CHECK INTO OUR SYSTEM TO SEE WHY, HOWEVER THIS PATIENT ISN'T FOLLOWED REMOTELY SO THERE WAS NO WELL TO TELL WHAT THE CAUSE OF THE SYNCOPE WAS. EFFORTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. TO DATE, NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612192 ALTRUA IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND S403

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Life Threatening 4136| S403| 4135