BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR

    MDR report key: 11909341 · Received May 31, 2021

    Report

    Report Number
    3006630150-2021-02531
    Event Type
    Injury
    Date Received
    May 31, 2021
    Date of Event
    May 11, 2017
    Report Date
    May 31, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXACT DATE UNKNOWN, EVENT OCCURRED FOUR YEARS AGO FROM THE DATE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC2138700. MODEL: SC-2138-70. SERIAL: (B)(4). BATCH: 142286. PRODUCT FAMILY: SCS-IPG-R. UPN: M365SC11100. MODEL: SC-1110. SERIAL: (B)(4). BATCH: 165933.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A TUMOR AND THE LEADS CAME OUT OF THE BACK. ALL DEVICE COMPONENTS WERE EXPLANTED AND WERE NOT RETURNED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804511 LINEAR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2138-70 142005

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention