BEUDAMED
    FDA Adverse Event Injury Summary report: N

    8CH INFINITY DBS FLEX EXTN KIT, 60CM, B

    MDR report key: 8622570 · Received May 19, 2019

    Report

    Report Number
    1627487-2019-05713
    Event Type
    Injury
    Date Received
    May 19, 2019
    Report Date
    June 14, 2019
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    MHY
    UDI-DI
    05415067020857
    PMA / PMN Number
    P140009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REFERENCE NUMBERS: 1627487-2019-05711. 1627487-2019-05712. 1627487-2019-05713.

    Description of Event or Problem · 1

    REFERENCE MFR REPORT: 1627487-2019-05711, 1627487-2019-05712. IT WAS REPORTED THAT THE PATIENT EXPERIENCED GENERAL DISCOMFORT AND DISSATISFACTION WITH THE SYSTEM. IN TURN, THE SYSTEM WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415965 8CH INFINITY DBS FLEX EXTN KIT, 60CM, B DBS EXTENSION MHY ST. JUDE MEDICAL - NEUROMODULATION 6372 6705825 05415067020857

    Patients

    Seq Age Sex Outcome Treatment
    1 Other