BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 8122366 · Received December 1, 2018

    Report

    Report Number
    3006630150-2018-62038
    Event Type
    Injury
    Date Received
    December 1, 2018
    Date of Event
    November 14, 2018
    Report Date
    November 30, 2018
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767725
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-2218-50; SERIAL NUMBER: (B)(4); BATCH/LOT NUMBER: 5042720; MODEL/CATALOG DESCRIPTION: LINEAR ST LEAD KIT 50 CM.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT LOST EFFECTIVE COVERAGE DUE TO LEAD MIGRATION WHICH CONFIRMED VIA X-RAY. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE WHEREIN LEAD WAS REPOSITIONED. THE PATIENT WAS REPORTEDLY DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    961618 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-50 5000357 08714729767725

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention