BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEU_INS_STIMULATOR

    MDR report key: 8797809 · Received July 17, 2019

    Report

    Report Number
    3007566237-2019-01569
    Event Type
    Injury
    Date Received
    July 17, 2019
    Date of Event
    June 4, 2019
    Report Date
    July 17, 2019
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 977A290, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2019, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 977A290, SERIAL/LOT #: (B)(4), UBD: 14-DEC-2021, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE VECTRIS LEAD KIT WHICH WAS UNDER PRODUCT HOLD PLAN (PHO) WAS IMPLANTED IN THE PATIENT. THE MANUFACTURE REPRESENTATIVE WAS NOTIFIED ABOUT THE PHO AFTER THE EVENT. THE VECTRIS LEAD KIT WAS UNDER FCA WHICH MAY RESULT IN A USAGE DIFFICULTY. DURING THE PROCEDURE, THE LEAD WAS DIFFICULT TO MOVE AND PLACE TO THE DESIRED TARGET. THE PROCEDURE TOOK LONGER AND THE FINAL LEAD PLACEMENT WAS NOT AS EXPECT. IT WAS ALSO NOTED THAT THE STIMULATION COULDN¿T COVER THE PAIN AREA. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594446 NEU_INS_STIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention