BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-6

    MDR report key: 10791148 · Received November 5, 2020

    Report

    Report Number
    3006630150-2020-05353
    Event Type
    Injury
    Date Received
    November 5, 2020
    Date of Event
    October 12, 2020
    Report Date
    November 4, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729789567
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2366-70, SERIAL: (B)(4), BATCH: 7070534. PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2366-70, SERIAL: (B)(4), BATCH: 5167182.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENTS LEAD WAS PROTRUDING THROUGH THE SKIN. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE LEAD WAS CUT FROM THE ANCHOR AND REMOVED THE PATIENT WAS DOING WELL POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1262294 LINEAR 3-6 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2366-70 7070105 08714729789567

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention