BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLIK X

    MDR report key: 17188075 · Received June 22, 2023

    Report

    Report Number
    3006630150-2023-03609
    Event Type
    Injury
    Date Received
    June 22, 2023
    Date of Event
    February 21, 2023
    Report Date
    June 22, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729905318
    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 COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2366700. MODEL: SC-2366-70. SERIAL: (B)(4). BATCH: 7072380. PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2366700 . MODEL: SC-2366-70. SERIAL: (B)(4). BATCH: 7072961. PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2366700. MODEL: SC-2366-70. SERIAL: (B)(4). BATCH: 7072979. PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2366700 . MODEL: SC-2366-70. SERIAL: (B)(4). BATCH: 7072373. PRODUCT FAMILY: SCS-LEAD FIXATION. UPN: M365SC43180 . MODEL: SC-4318. BATCH: 29280665. PRODUCT FAMILY: SCS-LEAD FIXATION. UPN: M365SC43180 . MODEL: SC-4318. BATCH: 26890198.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED BURNING PAIN AND DISCOMFORT AT THEIR SPINAL CORD STIMULATION (SCS) ANCHOR SITE. THE PHYSICIAN ASSESSED THAT THE PAIN WAS CAUSED BY THE PLACEMENT OF THE ANCHORS. THE PATIENT'S DEVICE WAS REPROGRAMMED, HOWEVER, THE REPORTED ISSUE PERSISTED. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE ANCHORS AND LEADS WERE EXPLANTED AND REPLACED. THE PATIENT IS DOING WELL POST-OPERATIVELY. THE DEVICES WERE DISCARDED BY THE MEDICAL FACILITY AND WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1002337 CLIK X STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-4318 26890198 08714729905318

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention