BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR 3-4

    MDR report key: 15451403 · Received September 19, 2022

    Report

    Report Number
    3006630150-2022-04864
    Event Type
    Injury
    Date Received
    September 19, 2022
    Date of Event
    July 6, 2022
    Report Date
    September 19, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729789581
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT FAMILY: LINEAR 3-6. UPN: M365SC2366500. MODEL: SC-2366-50. SERIAL: (B)(4). BATCH: 5168764. PRODUCT FAMILY: LINEAR 3-6. UPN: M365SC2366500. MODEL: SC-2366-50. SERIAL: (B)(4). BATCH: 5001487. PRODUCT FAMILY: LINEAR 3-4. UPN: M365SC2352700. MODEL: SC-2352-70. SERIAL: (B)(4). BATCH: 5110055. PRODUCT FAMILY: SCS-LINEAR FIXATION. UPN: M365SC43160. MODEL: SC-4316. SERIAL: N/A. LOT: 23058780.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT EXPERIENCED INADEQUATE STIMULATION TO THE APPROPRIATE PAIN AREA DUE TO LEAD MIGRATION. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE WHERE THE SPINAL CORD STIMULATION LEADS WERE EXPLANTED AND REPLACED WITH AN UPGRADED SYSTEM. THE PATIENT WAS STABLE POSTOPERATIVELY. THE EXPLANTED DEVICES WERE NOT RETURNED AS THEY WERE RETAINED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1435398 LINEAR 3-4 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2352-70 7044284 08714729789581

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention