BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? 3-4

    MDR report key: 21595473 · Received March 13, 2025

    Report

    Report Number
    3006630150-2025-01475
    Event Type
    Injury
    Date Received
    March 13, 2025
    Date of Event
    January 29, 2025
    Report Date
    May 20, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729789550
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2352500. MODEL: SC-2352-50. SERIAL: (B)(6). BATCH: 7080467.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED TO CORRECT THE UNIQUE IDENTIFIER (UDI) # FIELD (D4) IN SECTION D, SUSPECT MEDICAL DEVICE. BLOCK D2B: LGW, QRB.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS BREAKING INTO HIVES AND HAD AN ALLERGIC REACTION WHICH WAS PROBABLY DUE TO THE ADHESIVE FROM THE BANDAGE AT THE BACK FOLLOWING AN IMPLANT PROCEDURE. THE PATIENT WAS SENT TO THE (ER) EMERGENCY ROOM DUE TO AN INFECTION WHICH WAS POSSIBLY RELATED WITH SEPSIS. THE PATIENT'S DEVICES WERE REMOVED AND WOUND VACUUM WAS PLACED OVER THE INCISION SITE. NO COMPLICATIONS WERE NOTED DURING THE PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE INFECTION WERE NOTED ON BOTH IPG AND LEAD INCISION SITE. THE PHYSICIAN BELIEVED THAT THE CAUSE OF THE INFECTION WAS UNKNOWN BUT NOT DEVICE RELATED. THE PATIENT WAS PLACED ON ANTIBIOTICS AND THE EXPLANTED DEVICES WILL NOT BE RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS BREAKING INTO HIVES AND HAD AN ALLERGIC REACTION WHICH WAS PROBABLY DUE TO THE ADHESIVE FROM THE BANDAGE AT THE BACK FOLLOWING AN IMPLANT PROCEDURE. THE PATIENT WAS SENT TO THE (ER) EMERGENCY ROOM DUE TO AN INFECTION WHICH WAS POSSIBLY RELATED WITH SEPSIS. THE PATIENTS DEVICES WERE REMOVED AND WOUND VACUUM WAS PLACED OVER THE INCISION SITE. NO COMPLICATIONS WERE NOTED DURING THE PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS BREAKING INTO HIVES AND HAD AN ALLERGIC REACTION WHICH WAS PROBABLY DUE TO THE ADHESIVE FROM THE BANDAGE AT THE BACK FOLLOWING AN IMPLANT PROCEDURE. THE PATIENT WAS SENT TO THE (ER) EMERGENCY ROOM DUE TO AN INFECTION WHICH WAS POSSIBLY RELATED WITH SEPSIS. THE PATIENTS DEVICES WERE REMOVED AND WOUND VACUUM WAS PLACED OVER THE INCISION SITE. NO COMPLICATIONS WERE NOTED DURING THE PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE INFECTION WERE NOTED ON BOTH IPG AND LEAD INCISION SITE. THE PHYSICIAN BELIEVED THAT THE CAUSE OF THE INFECTION WAS UNKNOWN BUT NOT DEVICE RELATED. 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
    464055 LINEAR? 3-4 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2352-50 7080521 08714729789550

    Patients

    Seq Age Sex Outcome Treatment
    1