BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-6

    MDR report key: 18783200 · Received February 26, 2024

    Report

    Report Number
    3006630150-2024-00974
    Event Type
    Injury
    Date Received
    February 26, 2024
    Date of Event
    February 1, 2024
    Report Date
    February 26, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729789574
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BRAND NAME: LINEAR 3-6 LEAD, UPN: M365SC2366500, MODEL: SC-2366-50, SERIAL: (B)(6), BATCH: 7072585. BRAND NAME: PRECISION, UPN: M365SC9218150, MODEL: SC-9218-15, SERIAL: (B)(6), BATCH: 7063425. BRAND NAME: PRECISION, UPN: M365SC9218150, MODEL: SC-9218-15, SERIAL: (B)(6), BATCH: 5177778. BRAND NAME: SPECTRA WAVEWRITER, UPN: M365SC11600, MODEL: SC-1160, SERIAL: (B)(6), BATCH: 374077.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS SPINAL CORD STIMULATION LEADS DISPLAYED HIGH IMPEDANCES. IT IS UNKNOWN IF THERE WERE SYMPTOMS DUE TO THE IMPEDANCES. THE PATIENT UNDERWENT A PROCEDURE WHERE TWO LEADS, TWO LEAD ADAPTERS AND THE IPG WERE REPLACED. THERE WERE NO REPORTED COMPLICATIONS POSTOPERATIVELY. THE DEVICES WILL NOT BE RETURNED AS THEY WERE RETAINED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2212698 LINEAR 3-6 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2366-50 7072420 08714729789574

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention