BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DYNAGEN

    MDR report key: 3904535 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-11782
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    December 30, 2013
    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, DIFFICULTY WAS EXHIBITED WHEN INSERTING THE LEFT VENTRICULAR LEAD INTO THIS DEVICE'S RESPECTIVE HEADER PORT. THE PHYSICIAN REPORTED THAT INSERTION WAS ATTEMPTED TWO TIMES, IN ORDER TO ENSURE A PROPER CONNECTION. THE PROCEDURE WAS COMPLETED WITH SUCCESS AND TO DATE, NO ADDITIONAL COMPLICATIONS OR ADVERSE PATIENT EFFECTS, HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383142 DYNAGEN IMPLANTABLE CHF GENERATOR LWP GUIDANT CRM CLONMEL IRELAND G158

    Patients

    Seq Age Sex Outcome Treatment
    1 0692| G158| 4677| MISMATCH