BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DA+ C SERIES DR

    MDR report key: 1922126 · Received December 13, 2010

    Report

    Report Number
    6000144-2010-05863
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    September 7, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    P990001/S017
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VE
    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. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THERE WAS A MISSING SET SCREW PART.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE VENTRICULAR LEAD SETSCREW HAD NO RESISTANCE TO THE ROTATION OF THE SCREWDRIVER AND DID NOT MAKE THE NOISES TYPICALLY MADE WHEN TIGHTENING THE SETSCREW. WHEN THE SCREWDRIVER WAS REMOVED, THE SETSCREW WAS ALSO REMOVED. THE DEVICE WAS NOT USED AND ANOTHER DEVICE WAS SUCCESSFULLY IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DA+ C SERIES DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. C60A3 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 79 DA Other