BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA 300 SR

    MDR report key: 2053308 · Received April 13, 2011

    Report

    Report Number
    6000094-2011-00536
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    February 3, 2011
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S2
    Removal / Correction Number
    Z-1510/1519-2009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    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) NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CAME TO THE CLINIC BECAUSE OF SYNCOPAL EVENTS. THE INTERROGATION DID NOT REVEAL ANY CAUSE FOR THE SYMPTOMS. THE PHYSICIAN DECIDED TO EXPLANT AND REPLACE THE DEVICE SINCE IT WAS A PART OF THE FIELD ACTION. 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 SR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC S.A. SSR303 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R