BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 18276229 · Received December 6, 2023

    Report

    Report Number
    3006630150-2023-07670
    Event Type
    Injury
    Date Received
    December 6, 2023
    Date of Event
    October 28, 2023
    Report Date
    December 6, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767749
    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: BRAND NAME: LINEAR ST. UPN: M365SC2218700. MODEL: SC-2218-70. SERIAL: (B)(6). BATCH: 7092238. BRAND NAME: CLIK X. UPN: M365SC43180. MODEL: SC-4318. SERIAL: NULL. BATCH: 31666362.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED ITCHING FOR A COUPLE OF WEEKS, REDNESS AND DISCHARGE FROM THE SPINAL CORD STIMULATOR (SCS) LEAD AND CLIK ANCHOR SITE. IT WAS DETERMINED THAT THE PATIENT HAD DEVELOPED AN INFECTION. THE PATIENT UNDERWENT A PROCEDURE IN WHICH THE PHYSICIAN REOPENED THE INCISION SITE, AND DETERMINED THAT THE INFECTION WAS SUPERFICIAL AND ABOVE THE CLIK ANCHOR. THE PHYSICIAN CLEANED OUT THE WOUND WITH A BETADINE FLUSH REMOVED THE STITCH AND CLOSED THE INCISION, THE PATIENT WAS PRESCRIBED ANTIBIOTICS AND IS DOING WELL POST OPERATIVELY. CULTURES WERE TAKE BUT THE RESULTS ARE UNKNOWN. NO DEVICES WILL BE RETURNED AS THEY ALL REMAIN IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1845888 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 7091688 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention