BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA 200 DR

    MDR report key: 1992365 · Received February 15, 2011

    Report

    Report Number
    6000094-2011-00314
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    December 28, 2010
    Manufacturer
    MEDTRONIC S.A.
    Product Code
    DXY
    PMA / PMN Number
    P980035/S2
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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) ANALYSIS OF THE DEVICE FOUND THE NO OUTPUT AND NO TELEMETRY CONDITIONS WERE THE RESULT OF LIFTED HYBRID BOND WIRES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE TRAVELING, THE PATIENT BECAME SYMPTOMATIC. DURING INTERROGATION, THERE WAS NO PACING SPIKE ON THE ELECTROCARDIOGRAM. THE DEVICE HAD NO OUTPUT. THE PACEMAKER WAS REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE TRAVELING, THE PATIENT BECAME SYMPTOMATIC. DURING INTERROGATION, THERE WAS NO PACING SPIKE ON THE ELECTROCARDIOGRAM. THE DEVICE HAD NO OUTPUT. THE PACEMAKER WILL BE REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA 200 DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC S.A. SDR203 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R