BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DYNAGEN

    MDR report key: 3904536 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-11790
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    January 20, 2014
    Report Date
    April 15, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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 DURING IMPLANT, THE PHYSICIAN REPORTED DIFFICULTY INSERTING THE RIGHT AND LEFT VENTRICULAR LEADS INTO THIS DEVICE'S HEADER. WITH ADDITIONAL FORCE, THE LEADS WERE SUCCESSFULLY IMPLANTED: TO DATE, THE SYSTEM REMAINS IMPLANTED AND IN SERVICE WITH NO FURTHER REPORTED COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383467 DYNAGEN IMPLANTABLE CHF GENERATOR LWP GUIDANT CRM CLONMEL IRELAND G158

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR 0693| G158| MISMATCH| 4675