BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINEAR? ST

    MDR report key: 21912918 · Received April 25, 2025

    Report

    Report Number
    3006630150-2025-02807
    Event Type
    Malfunction
    Date Received
    April 25, 2025
    Date of Event
    April 2, 2025
    Report Date
    August 24, 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
    OK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SC-2218-70 (SN (B)(6)): THE RETURNED LEAD WAS ANALYZED AND WITH ALL THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDES THAT THE REPORTED EVENT WAS NOT CONFIRMED. THE CLEAN-CUT DAMAGE IS A RESULT OF A TYPICAL EXPLANT PROCEDURE, AND IT IS NOT CONSIDERED A FAILURE. HOWEVER, A LABELLING REVIEW FOUND THAT THE REPORTED EVENT IS A KNOWN RISK OF IMPLANTING A PULSE GENERATOR AS PART OF A SYSTEM TO DELIVER SPINAL CORD STIMULATION. SC-1416 (SN (B)(6)): THE RETURNED IPG WAS ANALYZED, PASSED ALL TESTS PERFORMED, AND EXHIBITED NORMAL DEVICE CHARACTERISTICS. THE REPORTED EVENT WAS NOT CONFIRMED. AN ANALYSIS OF THE DATA LOG INDICATES THAT THE IPG HAS NOT REACHED THE END OF ITS LIFE, AS THE BATTERY VOLTAGE REMAINS WITHIN THE REQUIRED THRESHOLD, AND THE IPG EXHIBITED TYPICAL CHARACTERISTICS DURING THE FUNCTIONAL ASSESSMENT.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(6), BATCH: 7087950, UDI:(B)(4). PRODUCT FAMILY: SCS-IPG-PC UPN: M365SC14160, MODEL: SC-1416, SERIAL: (B)(6), BATCH: 213231, UDI:(B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENTS LEADS HAD MIGRATED AND WAS FRACTURED AFTER A FALL. THE LEADS HAD HIGH IMPEDANCES AND PATIENT EXPERIENCED INADEQUATE STIMULATION. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS NON-FUNCTIONAL. ALL COMPONENTS WERE EXPLANTED, AND PATIENT WAS DOING WELL POSTOPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENTS LEADS HAD MIGRATED AND WAS FRACTURED AFTER A FALL. THE LEADS HAD HIGH IMPEDANCES AND PATIENT EXPERIENCED INADEQUATE STIMULATION. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS NON-FUNCTIONAL. ALL COMPONENTS WERE EXPLANTED, AND PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346253 LINEAR? ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION CORPORATION SC-2218-70 7087633 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Required Intervention