BEUDAMED
    FDA Adverse Event Injury Summary report: N

    50CM IMPLANT LEAD KIT, SLIM TIP

    MDR report key: 8663980 · Received June 3, 2019

    Report

    Report Number
    1627487-2019-06439
    Event Type
    Injury
    Date Received
    June 3, 2019
    Date of Event
    May 13, 2019
    Report Date
    June 12, 2019
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    PMP
    UDI-DI
    05415067025531
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 NUMBER: 1627487-2019-06437. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2019-06438 . RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2019-06440. RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2019-06473.

    Description of Event or Problem · 1

    RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2019-06437, RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2019-06438, RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2019-06440, RELATED MANUFACTURER REFERENCE NUMBER: 1627487-2019-06473. IT WAS REPORTED THAT PATIENT WAS NOT RECEIVING EFFECTIVE THERAPY. IN TURN, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE ENTIRE DRG SYSTEM WAS EXPLANTED WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456849 50CM IMPLANT LEAD KIT, SLIM TIP DRG LEAD PMP ST. JUDE MEDICAL - NEUROMODULATION MN10450-50A AB2212 05415067025531

    Patients

    Seq Age Sex Outcome Treatment
    1 Other MODEL MN10200, DRG INS| MODEL MN10450-50A, DRG LEAD| MODEL MN10450-50A, DRG LEAD| MODEL MN10450-50A, DRG LEAD