BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA 300 DR

    MDR report key: 1072836 · Received July 10, 2008

    Report

    Report Number
    2647346-2008-00299
    Event Type
    Injury
    Date Received
    July 10, 2008
    Date of Event
    July 11, 2007
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DXY
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    Z-1510/1519-2009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY - (B) (4) - ANALYSIS SHOWED NO OUTPUT CONDITION WAS THE RESULT OF LIFTED HYBRID BOND WIRES. FURTHER INFORMATION RECEIVED IS INCONCLUSIVE AS TO WHETHER OR NOT THE DEVICE WAS FUNCTIONING AT THE TIME OF EXPLANT AND NO INFORMATION WAS RECEIVED TO SUGGEST A PRODUCT PROBLEM. THEREFORE THE CONCLUSION HAS BEEN UPDATED TO REFLECT THIS.

    Description of Event or Problem · 1

    (B) (4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA 300 DR IMPLANTABLE PULSE GENERATOR DXY MEDTRONIC MED REL, INC. SDR303 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other 5076 IMPLANTABLE PACING LEAD