BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-6

    MDR report key: 18424648 · Received January 2, 2024

    Report

    Report Number
    3006630150-2023-08278
    Event Type
    Injury
    Date Received
    January 2, 2024
    Date of Event
    December 14, 2022
    Report Date
    January 2, 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

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: BRAND NAME: LINEAR 3-4, UPN: M365SC2352700, MODEL: SC-2352-70, SERIAL: (B)(6), BATCH: 5110055 AND 7044284. BRAND NAME: LINEAR 3-6, UPN: M365SC2366500, MODEL: SC-2366-50, SERIAL: (B)(6), BATCH: 5168764.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED A LUMP AND EXPERIENCED PAIN AT THE SPINAL CORD STIMULATION LEAD ANCHOR INCISION SITE WHICH HAD SLOWLY DEVELOPED OVER THE LAST FEW WEEKS. THE LUMP WAS PALPATED OVER THE CONTOUR OF WHAT FELT TO BE THE LEAD ANCHOR. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE PHYSICIAN ATTEMPTED TO REPOSITION THE LEAD ANCHOR. HOWEVER, IT WAS FOUND DURING THIS PROCEDURE THAT THE LUMP WAS A LEAD TIP (NOT A LEAD ANCHOR) WHICH HAD REMAINED IMPLANTED FOLLOWING A PREVIOUS EXPLANT PROCEDURE (SEE MFR. 15347136, 3006630150-2022-04864). ONE OF THE FOUR REMAINING LEADS HAD BEEN CUT AND THE TIP THAT REMAINED IMPLANTED HAD BEEN CAUGHT IN SCAR TISSUE WHICH THEN CAUSED PAIN FOR THE PATIENT. THIS REMAINING PORTION OF THE LEAD WAS EXPLANTED AND WAS NOT RETURNED AS IT WAS DISCARDED BY THE MEDICAL FACILITY. THERE WERE NO REPORTED COMPLICATIONS POSTOPERATIVELY. THE PATIENT IS EXPECTED TO FULLY RECOVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1213470 LINEAR 3-6 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2366-50 5001487 08714729789574

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention