BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 15677765 · Received October 26, 2022

    Report

    Report Number
    3006630150-2022-05805
    Event Type
    Injury
    Date Received
    October 26, 2022
    Date of Event
    July 8, 2020
    Report Date
    April 20, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767749
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(6), BATCH: 7070255.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2218700. MODEL: SC-2218-70. SERIAL: (B)(6). BATCH: 7070255.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE PAIN COVERAGE DUE TO RIGHT LEAD MIGRATION. DECOMPRESSIVE THORACIC LAMINECTOMY WAS PERFORMED AND THE LEAD WAS REPLACED DURING THE PROCEDURE. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS REPROGRAMMED AND THE EVENT WAS RESOLVED. THE PHYSICIAN ASSESSED THE EVENT AS NOT RELATED TO PROCEDURE AND RELATED TO STUDY DEVICE SYSTEM (DEVICE HARDWARE, NOT STIMULATION).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE PAIN COVERAGE DUE TO RIGHT LEAD MIGRATION. DECOMPRESSIVE THORACIC LAMINECTOMY WAS PERFORMED AND THE LEAD WAS REPLACED DURING THE PROCEDURE. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS REPROGRAMMED AND THE EVENT WAS RESOLVED. THE PHYSICIAN ASSESSED THE EVENT AS NOT RELATED TO PROCEDURE AND RELATED TO STUDY DEVICE SYSTEM (DEVICE HARDWARE, NOT STIMULATION). ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT EXPERIENCED AN UNKNOWN ISSUE WITH ANOTHER LEAD. AN UNKNOWN ACTION WAS TAKEN AS A RESULT. ADDITIONAL INFORMATION WAS RECEIVED THAT THE CLINICAL STUDY SITE CONFIRMED THERE WAS NO LEAD MIGRATION OR OTHER DEVICE DEFICIENCY THAT OCCURRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE PAIN COVERAGE DUE TO RIGHT LEAD MIGRATION. DECOMPRESSIVE THORACIC LAMINECTOMY WAS PERFORMED AND THE LEAD WAS REPLACED DURING THE PROCEDURE. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS REPROGRAMMED AND THE EVENT WAS RESOLVED. THE PHYSICIAN ASSESSED THE EVENT AS NOT RELATED TO PROCEDURE AND RELATED TO STUDY DEVICE SYSTEM (DEVICE HARDWARE, NOT STIMULATION). ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT EXPERIENCED AN UNKNOWN ISSUE WITH ANOTHER LEAD. AN UNKNOWN ACTION WAS TAKEN AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2453225 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 7073134 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Required Intervention