BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 20062373 · Received August 26, 2024

    Report

    Report Number
    3006630150-2024-05583
    Event Type
    Injury
    Date Received
    August 26, 2024
    Date of Event
    November 1, 2023
    Report Date
    August 26, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED IN NOVEMBER 2023. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2218500, MODEL: SC-2218-50, SERIAL: (B)(6), BATCH: 7110636. PRODUCT FAMILY: SCS-IPG-R, UPN: M365SC11600, MODEL: SC-1160, SERIAL: (B)(6), BATCH: 371146.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING INADEQUATE PAIN RELIEF DUE TO HIGH IMPEDANCES NOTED ON THE SPINAL CORD STIMULATOR (SCS) LEADS. REPROGRAMMING WAS ATTEMPTED, HOWEVER, UNSUCCESSFUL. IT WAS ALSO NOTED THAT THE PATIENTS IMPLANTABLE PULSE GENERATOR (IPG) WAS NOT KEEPING A CHARGE. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE SCS LEADS AND IPG WERE REPLACED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. NO DEVICE MALFUNCTION WAS SUSPECTED. THE EXPLANTED IPG AND LEADS WERE NOT RETURNED DUE TO HOSPITAL POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1293997 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 7110593 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male Required Intervention