BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-6

    MDR report key: 11285322 · Received February 5, 2021

    Report

    Report Number
    3006630150-2021-00295
    Event Type
    Injury
    Date Received
    February 5, 2021
    Date of Event
    December 21, 2020
    Report Date
    February 5, 2021
    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: 7070948.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS RECEIVING INADEQUATE STIMULATION TO RIGHT THORACIC PAIN AREA. AN X-RAY CONFIRMED THAT THE RIGHT LEAD HAD MIGRATED. IT IS NOT KNOWN WHICH OF THE TWO LEAD SERIAL NUMBERS WAS THE RIGHT LEAD. THE PATIENT UNDERWENT A REVISION PROCEDURE AND RATHER THAN REVISING THE LEAD THAT MIGRATED, THE PHYSICIAN IMPLANTED TWO ADDITIONAL LEADS TO COVER THE ORIGINAL RIGHT THORACIC PAIN SHE WAS IMPLANTED FOR, AS WELL AS ONE HIGHER IN THE RIGHT UPPER BACK TO TREAT THAT PAIN AREA AS WELL. NO DEVICES WERE EXPLANTED. THE PATIENT WAS DOING WELL POST OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183065 LINEAR 3-6 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2366-70 7070930 08714729789567

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R