BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 11546999 · Received March 22, 2021

    Report

    Report Number
    3006630150-2021-01138
    Event Type
    Injury
    Date Received
    March 22, 2021
    Date of Event
    January 13, 2021
    Report Date
    March 22, 2021
    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
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2218-70, SERIAL: (B)(4), BATCH: 7070528. PRODUCT FAMILY: SCS-LEAD FIXATION: UPN: (B)(4), MODEL: SC-4318, SERIAL: N/A, BATCH: 25808107. PRODUCT FAMILY: SCS-LEAD FIXATION: UPN: (B)(4), MODEL: SC-4318, SERIAL: N/A, BATCH: 24856290. PRODUCT FAMILY: SCS-LINEAR LEADS: UPN: (B)(4), MODEL:SC-2352-70 , SERIAL: (B)(4), BATCH: 7070046. PRODUCT FAMILY: SCS-LINEAR LEADS: UPN: (B)(4), MODEL: SC-2352-70 , SERIAL: (B)(4), BATCH: 7070032.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS NOT RECEIVING PARESTHESIA IN THE CORRECT LOCATION AND UNDERWENT A REVISION PROCEDURE DUE TO LEAD MIGRATION OF BOTH LEADS. DURING THE REVISION, THE PHYSICIAN DISCOVERED THAT THE CLIK ANCHORS WERE NOT ADEQUATELY SECURED. THE PHYSICIAN BELIEVES THE MIGRATION MAY HAVE OCCURRED IMMEDIATELY FOLLOWING THE IMPLANT PROCEDURE. THE PATIENT WAS DOING WELL POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442354 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 7070578 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention