BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGMA 300 DR

    MDR report key: 1924428 · Received December 14, 2010

    Report

    Report Number
    6000094-2010-02258
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    September 27, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S2
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 THE SET SCREW WAS LODGED.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE (B)(6). 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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, THE DOCTOR WAS UNABLE TO CONNECT THE LEAD TO THE PACEMAKER. THE PACEMAKER WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT DOCTOR WAS UNABLE TO CONNECT THE LEAD TO THE PACEMAKER. THE PACEMAKER WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA 300 DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC S.A. SDR303 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other