BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-4

    MDR report key: 21050393 · Received December 31, 2024

    Report

    Report Number
    3006630150-2024-09180
    Event Type
    Injury
    Date Received
    December 31, 2024
    Date of Event
    October 29, 2024
    Report Date
    December 31, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729789550
    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: BRAND NAME: LINEAR 3-4 UPN: M365SC2352500 MODEL: SC-2352-50 SERIAL: (B)(6). BATCH: 7080068.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOLLOWING A LEAD REVISION PROCEDURE (SEE MFR. REPORT 3006630150-2024-07951) THE PATIENT DEVELOPED A STAPHYLOCOCCUS AUREUS INFECTION AT THE SPINAL CORD STIMULATION LEAD SITE. THE PATIENT UNDERWENT A LEAD EXPLANT PROCEDURE, WAS ADMINISTERED FLUCLOXACILLIN, AND WAS DOING WELL POSTOPERATIVELY. THE PHYSICIAN ASSESSED THE INFECTION WAS DEVICE RELATED. THE DEVICES WERE NOT RETURNED AS THEY WERE RETAINED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2525959 LINEAR 3-4 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2352-50 7081959 08714729789550

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Male Required Intervention