BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 13077713 · Received December 23, 2021

    Report

    Report Number
    3006630150-2021-07212
    Event Type
    Injury
    Date Received
    December 23, 2021
    Date of Event
    December 1, 2021
    Report Date
    April 18, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767749
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS LINER LEADS, UPN: M365SC2218700, MODEL: SC-2218-70, SERIAL: (B)(4), BATCH: 7080813.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S LEADS HAD MIGRATED AND WAS PROTRUDING OUT AND THE PATIENTS HUSBAND PULLED AND CUT IT AND THAT WOULD BE THE REASON FOR MIGRATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS LEADS HAD MIGRATED AND WAS PROTRUDING OUT AND THE PATIENTS HUSBAND PULLED AND CUT IT AND THAT WOULD BE THE REASON FOR MIGRATION. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN NEW CLICK ANCHORS WERE ADDED AND THE EXISTING LEADS WERE REPOSITIONED AND REMAIN IMPLANTED. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1971613 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 5096495 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female Required Intervention