BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 16788101 · Received April 21, 2023

    Report

    Report Number
    3006630150-2023-02180
    Event Type
    Injury
    Date Received
    April 21, 2023
    Date of Event
    March 3, 2023
    Report Date
    June 16, 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
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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)(4). BATCH: 7087075 PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2366700 MODEL: SC-2366-70 SERIAL: (B)(4). BATCH: 7073553 PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2366700 MODEL: SC-2366-70 SERIAL: (B)(4). BATCH: 7073572.

    Additional Manufacturer Narrative · 0

    WITH THE AVAILABLE INFORMATION, BOSTON SCIENTIFIC CONCLUDED THROUGH LABORATORY ANALYSIS THAT INADEQUATE STIMULATION DUE TO LEAD MIGRATION IS A KNOWN RISK ASSOCIATED WITH THE USE OF THE DEVICE. AS IS STATED IN THE INSTRUCTIONS FOR USE, LEAD MIGRATION RESULTING IN UNDESIRABLE CHANGES IN STIMULATION ARE KNOWN RISK ASSOCIATED WITH THE USE OF THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOLLOWING A FALL THE PATIENT EXPERIENCED PAIN DUE TO LEAD MIGRATION. THE PATIENT'S DEVICE WAS REPROGRAMMED DUE TO INADEQUATE STIMULATION, HOWEVER, THE REPORTED ISSUE OF PAIN PERSISTED. THE PATIENT HAD X-RAYS TAKEN CONFIRMING THE MIGRATION OF ALL FOUR LEADS AND UNDERWENT A LEAD REVISION PROCEDURE WHERE TWO LEADS WERE EXPLANTED AND REPLACED. THE PATIENT WAS DOING WELL POST-OPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOLLOWING A FALL THE PATIENT EXPERIENCED PAIN DUE TO LEAD MIGRATION. THE PATIENT'S DEVICE WAS REPROGRAMMED DUE TO INADEQUATE STIMULATION, HOWEVER, THE REPORTED ISSUE OF PAIN PERSISTED. THE PATIENT HAD X-RAYS TAKEN CONFIRMING THE MIGRATION OF ALL FOUR LEADS AND UNDERWENT A LEAD REVISION PROCEDURE WHERE TWO LEADS WERE EXPLANTED AND REPLACED. THE PATIENT WAS DOING WELL POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684255 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 7080995 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention