BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-6

    MDR report key: 17003338 · Received May 25, 2023

    Report

    Report Number
    3006630150-2023-02958
    Event Type
    Injury
    Date Received
    May 25, 2023
    Date of Event
    March 21, 2023
    Report Date
    May 25, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729789567
    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: M365SC2366700, MODEL: SC-2366-70, SERIAL: (B)(6), BATCH: 7070948. PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2366700, MODEL: SC-2366-70, SERIAL: (B)(6), BATCH: 7071620. PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2366700, MODEL: SC-2366-70, SERIAL: (B)(6), BATCH: 7071331. PRODUCT FAMILY: SCS-IPG-R, UPN: M365SC11600, MODEL: SC-1160, SERIAL: (B)(6), BATCH: 370162.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED SPINAL CORD STIMULATION (SCS) LEAD MIGRATION AND THE LEAD PULLED INTO THE IMPLANTABLE PULSE GENERATOR (IPG) POCKET. THE PATIENT STATED THAT SHE LOST WEIGHT AND THE IPG WAS CAUSING HER PAIN. ADDITIONALLY, THE PATIENT MENTIONED HAVING A SERIOUS FALL APPROXIMATELY EIGHT MONTHS AGO. IT IS UNKNOWN IF THE FALL CONTRIBUTED TO THE LEAD MIGRATION. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE, AS THE PATIENT REQUESTED FOR THE ENTIRE SCS SYSTEM TO BE REMOVED FOR NOW, SO THAT SHE CAN FOCUS ON OTHER HEALTH CONCERNS AT THIS TIME. THE HOSPITAL RETAINED ALL EXPLANTED PRODUCTS, SO PRODUCTS WILL BE RETURNED FOR ANALYSIS. THE PATIENT WAS RECOVERING WELL WITH NO POST-OP COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1516295 LINEAR 3-6 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2366-70 7070930 08714729789567

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention