BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-4

    MDR report key: 13625570 · Received February 28, 2022

    Report

    Report Number
    3006630150-2022-00744
    Event Type
    Injury
    Date Received
    February 28, 2022
    Date of Event
    December 21, 2021
    Report Date
    June 6, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729789581
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: EXACT DATE UNKNOWN, EVENT OCCURRED IN (B)(6) 2021. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2352700, MODEL: SC-2352-70, SERIAL: (B)(4), BATCH: 7072605.

    Additional Manufacturer Narrative · 0

    BLOCK B5: CORRECTION TO THE INITIAL MDR BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED IN (B)(6) 2021 ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2352700 MODEL: SC-2352-70 SERIAL: (B)(6). BATCH: 7072605.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE PAIN RELIEF AND A RETURN OF HEADACHE SYMPTOMS SHORTLY AFTER BEING IMPLANTED WITH THE DEEP BRAIN STIMULATION (DBS) SYSTEM. IT WAS CONFIRMED VIA X-RAY THAT BOTH THE LEADS MIGRATED. THE PHYSICIAN USED OFF-LABEL SOFT SILICON ANCHORS INSTEAD OF BOSTON SCIENTIFIC CLIK ANCHORS FOR THE PROCEDURE. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE WHEREIN BOTH LEADS AND CLIKS WERE REPLACED. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY AS PER THEIR POLICY. THE PATIENT WAS DOING WELL POST-OPERATIVELY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE PAIN RELIEF AND A RETURN OF HEADACHE SYMPTOMS SHORTLY AFTER BEING IMPLANTED WITH THE SPINAL CORD STIMULATION (SCS) SYSTEM. IT WAS CONFIRMED VIA X-RAY THAT BOTH THE LEADS MIGRATED. THE PHYSICIAN USED OFF-LABEL SOFT SILICON ANCHORS INSTEAD OF BOSTON SCIENTIFIC CLIK ANCHORS FOR THE PROCEDURE. THE PATIENT UNDERWENT A LEAD REPLACEMENT PROCEDURE WHEREIN BOTH LEADS AND CLIKS REPLACED. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY AS PER THEIR POLICY. THE PATIENT WAS DOING WELL POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1863005 LINEAR 3-4 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2352-70 7072323 08714729789581

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention