BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 14840566 · Received June 28, 2022

    Report

    Report Number
    3006630150-2022-03139
    Event Type
    Injury
    Date Received
    June 28, 2022
    Date of Event
    May 12, 2022
    Report Date
    June 28, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767749
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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: M365SC2218700; MODEL: SC-2218-70; SERIAL: (B)(4); BATCH: 7081329. PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC2218500; MODEL: SC-2218-50; SERIAL: (B)(4); BATCH: 7098903.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD A SMALL AREA OF EDEMA UNDER THE LUMBAR INCISION THAT IS LIKELY A SEROMA. THE RIGHT LEAD HAD DESCENDED AND THE PATIENT HAD NOTED INCREASED SWELLING AND TENDERNESS. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEAD WILL NOT BE RETURNED PER HOSPITAL POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736095 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 7081253 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention