BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVISA DR

    MDR report key: 2130833 · Received June 16, 2011

    Report

    Report Number
    6000094-2011-01102
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    April 19, 2011
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    NVZ
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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 SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN CONNECTING THE LEAD INTO THE DEVICE, THERE WAS A PROBLEM WITH THE SETSCREW. IT APPEARED THAT THE SCREW WAS NOT TURNING OR "NOT BITING" AND THE CHARACTERISTIC SOUND WAS NOT HEARD. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVISA DR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC S.A. A3DR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other (B)(4) IMPLANTABLE PACING LEAD