BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-6

    MDR report key: 12808346 · Received November 14, 2021

    Report

    Report Number
    3006630150-2021-06431
    Event Type
    Injury
    Date Received
    November 14, 2021
    Date of Event
    November 19, 2020
    Report Date
    November 13, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729789574
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2366500, MODEL: SC-2366-50, SERIAL: (B)(4), BATCH: 7072053.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING POKING PAIN OVER THE LEFT LEAD TIP WHICH WORSENED WITH MOVEMENT AND ANY ACTIVITY WHERE PRESSURE WAS APPLIED TO THE AREA OVER THE LEAD, SUCH AS LEANING BACK IN A CHAIR. REPROGRAMMING WAS ATTEMPTED BUT WAS NOT SUCCESSFUL. THE STIMULATION IN THE LEFT LEAD WAS TURNED OFF AND THE STIMULATION IN THE RIGHT LEAD CONTINUED TO PROVIDE 100 PER CENT RELIEF OF THE PAIN AT THE BRA LINE. THE LEFT LEAD WAS REPOSITIONED AND THE PAINT AT THE LEAD SITE HAS RESOLVED. THE PATIENT IS DOING WELL POSTOPERATIVELY AND EXPERIENCING PAIN RELIEF. IT IS UNCLEAR WHICH SERIAL NUMBER BELONGS TO THE LEFT LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1706760 LINEAR 3-6 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2366-50 7072167 08714729789574

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention