BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA 200 DR

    MDR report key: 1991293 · Received February 15, 2011

    Report

    Report Number
    6000094-2011-00259
    Event Type
    Injury
    Date Received
    February 15, 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
    IT
    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) PRELIMINARY ANALYSIS REVEALED NO OUTPUT AND NO TELEMETRY. FURTHER TESTING REVEALED THAT THE NO OUTPUT AND NO TELEMETRY CONDITIONS WERE THE RESULT OF LIFTED HYBRID BOND WIRES. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE COULD NOT BE INTERROGATED. ON ELECTROGRAM ( ECG), IT WAS REPORTED THERE WAS JUST PATIENT INTRINSIC RHYTHM, NO STIMULATION BY THE PACEMAKER. THE DEVICE WAS EXTRACTED AND REPLACED. NO 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