BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9614453-2013-00409

    MDR report key: 2964985 · Received February 15, 2013

    Report

    Report Number
    9614453-2013-00409
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    November 8, 2012
    Report Date
    November 12, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    PMA / PMN Number
    P010031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED MALFUNCTION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, DURING THIS IMPLANT THE PHYSICIAN HAD DIFFICULTY LOCATING THE SET SCREW OF THE ATRIAL PORT. ADJUSTMENTS TO THE ANGEL WITH THE WRENCH MADE IT POSSIBLE TO AFIX THE SCREW AND THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS REPORTED THAT THERE WERE PROBLEMS TO FIND THE SCREW, ESPECIALLY THE ATRIAL ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68868 LWS IPG MFG SWITZERLAND DTBA2D4

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR