BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-4

    MDR report key: 13830916 · Received March 20, 2022

    Report

    Report Number
    3006630150-2022-01127
    Event Type
    Injury
    Date Received
    March 20, 2022
    Date of Event
    November 18, 2021
    Report Date
    March 18, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729789550
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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: M365SC2352700, MODEL: SC-2352-70, SERIAL: (B)(4), BATCH: 7073088/7072836/7073087.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A CEREBROSPINAL FLUID LEAK DUE TO A NON DEVICE RELATED LAMINECTOMY PROCEDURE. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE WHEREIN THE PHYSICIAN TRIED TO FIX THE LEAD PLACEMENTS BUT DID IT WRONG. THE PATIENT UNDERWENT ANOTHER LEAD REVISION PROCEDURE WHEREIN THE LINEAR LEADS WERE REPLACED WITH PADDLE LEADS. THE PATIENT WAS DOING WELL POST OPERATIVELY. THE EXPLANTED LEADS WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544432 LINEAR 3-4 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2352-50 7074439 08714729789550

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female Required Intervention