BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA 200 D

    MDR report key: 1924503 · Received December 14, 2010

    Report

    Report Number
    6000094-2010-02264
    Event Type
    Injury
    Date Received
    December 14, 2010
    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 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. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY: (B)(4) THE NO OUTPUT CONDITION WAS THE RESULT OF LIFTED HYBRID BOND WIRES. ANALYSIS OF THE DEVICE DATA WAS INCONCLUSIVE IF THERE WERE WIRE BOND LIFTS BEFORE OR AFTER EXPLANT BECAUSE THE EXPLANT DATE IS NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT FOLLOW-UP, UNIPOLAR PACING IMPEDANCE IN THE ATRIUM AND VENTRICLE WERE BOTH HIGH (>9999 OHMS) AND BIPOLAR WAS NORMAL. THE DEVICE WAS EXPLANTED 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 D IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC S.A. SD203 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R