BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-4

    MDR report key: 16833744 · Received April 28, 2023

    Report

    Report Number
    3006630150-2023-02357
    Event Type
    Injury
    Date Received
    April 28, 2023
    Date of Event
    April 19, 2023
    Report Date
    April 28, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729789581
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-IPG-PC. UPN: M365SC14160. MODEL: SC-1416. SERIAL: (B)(6). BATCH: 212389.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT EXPERIENCED STIMULATION IN THE IMPLANTABLE PULSE GENERATOR (IPG) POCKET, AND A LACK OF STIMULATION IN THEIR TARGETED PAIN AREA. THE PHYSICIAN ASSESSED THE FIXING SUTURE OF THE IPG CAME OFF THE FASCIA AND THE CAUSED THE IPG TO ROTATE RESULTING IN THE LEAD MIGRATING INTO THE POCKET. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE IPG WAS REPOSITIONED AND THE LEADS WERE REPLACED. THE PATIENT DID WELL POSTOPERATIVELY. PHYSICAL ANALYSIS COULD NOT BE PERFORMED, AS THE LEADS WERE DISCARDED BY THE FACILITY AND THE IPG REMAINS IMPLANTED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1235681 LINEAR 3-4 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2352-70 7075266 08714729789581

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention