BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINEAR ST

    MDR report key: 17421309 · Received July 28, 2023

    Report

    Report Number
    3006630150-2023-04431
    Event Type
    Injury
    Date Received
    July 28, 2023
    Date of Event
    June 27, 2022
    Report Date
    September 20, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767749
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO THE INITIAL MDR IN BLOCK G3 (BSC AWARE DATE). G3 SHOULD HAVE BEEN 28APR2023.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2218700 MODEL: SC-2218-70 SERIAL:(B)(6). BATCH: 7082444. PRODUCT FAMILY: SCS-IPG-PC UPN: M365SC14160 MODEL: SC-1416 SERIAL: (B)(6). BATCH: 2071666.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION DUE TO LEAD MIGRATION, AS CONFIRMED THROUGH INTERROGATION AND X-RAY. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG AND LEADS WERE REPLACED. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE KEPT BY THE MEDICAL FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION DUE TO LEAD MIGRATION, AS CONFIRMED THROUGH INTERROGATION AND X-RAY. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG AND LEADS WERE REPLACED. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE KEPT BY THE MEDICAL FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE STIMULATION DUE TO LEAD MIGRATION, AS CONFIRMED THROUGH INTERROGATION AND X-RAY. THE PATIENT UNDERWENT A REVISION PROCEDURE WHEREIN THE IPG AND LEADS WHERE REPLACED. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE KEPT BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2326236 LINEAR ST STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2218-70 7080183 08714729767749

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention