BEUDAMED
    FDA Adverse Event Injury Summary report: N

    50CM IMPLANT LEAD KIT, SLIM TIP

    MDR report key: 7975236 · Received October 17, 2018

    Report

    Report Number
    1627487-2018-10173
    Event Type
    Injury
    Date Received
    October 17, 2018
    Date of Event
    September 25, 2018
    Report Date
    October 17, 2018
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    PMP
    UDI-DI
    05415067025531
    PMA / PMN Number
    P150004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. THE MANUFACTURER DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 2 OF 2. REFERENCE MFR. REPORT#: 1627487-2018-010172. IT WAS REPORTED THE PATIENT DESIRED TO INCREASE STIMULATION COVERAGE TO HER PAINFUL AREA. AS SUCH, THE PATIENT UNDERWENT SURGICAL INTERVENTION (B)(6) 2018 WHEREIN TWO ADDITIONAL DRG LEADS WERE IMPLANTED FOR NEW/ADDITIONAL COVERAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    815458 50CM IMPLANT LEAD KIT, SLIM TIP DRG LEAD PMP ST. JUDE MEDICAL - NEUROMODULATION MN10450-50A AB2135 05415067025531

    Patients

    Seq Age Sex Outcome Treatment
    1 Other MODEL MN 10200, DRG IPG