BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-4

    MDR report key: 10756229 · Received October 29, 2020

    Report

    Report Number
    3006630150-2020-05247
    Event Type
    Injury
    Date Received
    October 29, 2020
    Date of Event
    September 28, 2020
    Report Date
    October 29, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729789550
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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-LINEAR LEADS, UPN: M365SC2352500, MODEL: SC-2352-50, SERIAL: (B)(4), BATCH: 7071202.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD PAIN AND SWELLING AT THE LEAD SITE INCISION. X-RAY WAS TAKEN AND SHOWED THAT THE LEADS WERE MIGRATED. THE PATIENT EXPERIENCED INADEQUATE STIMULATION AND REPROGRAMMING WAS DONE BUT UNABLE TO COVER LEFT SIDE. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEADS WERE REPOSITIONED AND WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1221747 LINEAR 3-4 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2352-50 7071157 08714729789550

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention