BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-6

    MDR report key: 15635618 · Received October 19, 2022

    Report

    Report Number
    3006630150-2022-05634
    Event Type
    Injury
    Date Received
    October 19, 2022
    Date of Event
    July 22, 2022
    Report Date
    October 19, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729789567
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: (B)(4). MODEL: SC-2366-70. SERIAL: (B)(4). BATCH: 5149316. PRODUCT FAMILY: SCS-LINEAR LEADS: UPN: (B)(4). MODEL: SC-2218-50. SERIAL: (B)(4). BATCH: 5108079/5112231.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS NOT GETTING GOOD STIMULATION ANYMORE DUE TO LEAD MIGRATION WHICH WAS CONFIRMED THROUGH AN X RAY. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE WHEREIN THE TWO FIFTY CENTIMETER LEADS WERE EXPLANTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY, AND THE EXPLANTED LEADS WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2562962 LINEAR 3-6 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2366-70 5141773 08714729789567

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Required Intervention