BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 2638826 · Received July 3, 2012

    Report

    Report Number
    3007566237-2012-01525
    Event Type
    Malfunction
    Date Received
    July 3, 2012
    Date of Event
    June 5, 2012
    Report Date
    June 5, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: NEU_STYLET_ACC, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 3874, LOT# V954418, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012, PRODUCT TYPE: SCREENING DEVICE. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A TRIAL IMPLANT, TWO DIFFERENT STYLETS GOT STUCK WHEN THEY WERE INSERTED INTO THE LEAD. A NEW TRIAL LEAD WAS USED AND THE IMPLANT WAS COMPLETED SUCCESSFULLY. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_ENS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1