BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 19521717 · Received June 12, 2024

    Report

    Report Number
    3006630150-2024-03790
    Event Type
    Injury
    Date Received
    June 12, 2024
    Date of Event
    September 1, 2023
    Report Date
    June 12, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED PRIOR TO THE DATE OF EXPLANT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218500. MODEL: SC-2218-50. SERIAL: (B)(6). BATCH: 7092626. PRODUCT FAMILY: SCS-IPG-R-MRI. UPN: M365SC12160. MODEL: SC-1216. SERIAL: (B)(6). BATCH: 524907. PRODUCT FAMILY: SCS-NON-SURG ACC. UPN: M365SC41080. MODEL: SC-4108. BATCH: 26850576.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE MIDLINE INCISION SITE WITH SIGNS OF REDNESS. IT WAS STATED THAT THE PATIENTS LEAD HAD MIGRATED AND THE LEAD SITE WAS NOT HEALING PROPERLY. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE PATIENT WAS PLACED ON ANTIBIOTICS AND THE EXPLANTED DEVICES WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153049 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 7092609 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention