BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR? ST

    MDR report key: 21185781 · Received January 17, 2025

    Report

    Report Number
    3006630150-2025-00086
    Event Type
    Injury
    Date Received
    January 17, 2025
    Date of Event
    December 13, 2024
    Report Date
    June 10, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    LGW
    UDI-DI
    08714729767749
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED TWO WEEKS PRIOR TO THE DATE THE MANUFACTURER BECAME AWARE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(6), BATCH: 7102563.

    Additional Manufacturer Narrative · 0

    SC-2218-70 (SN (B)(6)). UDI: (B)(4). SC-9218-55 (SN (B)(6)). UDI: (B)(4). SC-9218-55 (SN (B)(6)). UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-ADAPTERS, UPN: M365SC9218550, MODEL: SC-9218-55, SERIAL: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT FELL AND BUMPED THE INCISION WHERE THE LEADS WERE PLACED. THE INCISION SITE WAS IRRITATED, SWELLED UP, OPENED PARTIALLY AND STARTED TO DRAIN FLUID. A WOUND VAC BANDAGE WAS PLACED ON THE INCISION SITE. NO FURTHER INFORMATION COULD BE OBTAINED DESPITE GOOD FAITH EFFORTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT FELL AND BUMPED THE INCISION WHERE THE LEADS WERE PLACED. THE INCISION SITE WAS IRRITATED, SWELLED UP, OPENED PARTIALLY AND STARTED TO DRAIN FLUID. A WOUND VAC BANDAGE WAS PLACED ON THE INCISION SITE. NO FURTHER INFORMATION COULD BE OBTAINED DESPITE GOOD FAITH EFFORTS. ADDITIONAL INFORMATION WAS RECEIVED THAT AN INFECTION DEVELOPED AT THE LEAD SITE. IT WAS ALSO NOTED THAT THE LEAD ADAPTERS HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEADS WERE REMOVED AND LEAD ADAPTERS WERE REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE EXPLANTED DEVICES WERE DISPOSED OF PER FACILITY POLICY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT FELL AND BUMPED THE INCISION WHERE THE LEADS WERE PLACED. THE INCISION SITE WAS IRRITATED, SWELLED UP, OPENED PARTIALLY AND STARTED TO DRAIN FLUID. A WOUND VAC BANDAGE WAS PLACED ON THE INCISION SITE. NO FURTHER INFORMATION COULD BE OBTAINED DESPITE GOOD FAITH EFFORTS. ADDITIONAL INFORMATION WAS RECEIVED THAT AN INFECTION DEVELOPED AT THE LEAD SITE. IT WAS ALSO NOTED THAT THE LEAD ADAPTERS HAD HIGH IMPEDANCES. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEADS WERE REMOVED AND LEAD ADAPTERS WERE REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1140721 LINEAR? ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-70 7102545 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Required Intervention