BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 20212448 · Received September 13, 2024

    Report

    Report Number
    3006630150-2024-06071
    Event Type
    Injury
    Date Received
    September 13, 2024
    Date of Event
    August 17, 2024
    Report Date
    September 13, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729767688
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: TW# (B)(4), PRODUCT FAMILY: SCS-IPG-R, UPN: M365SC1110020, MODEL: SC-1110-02, SERIAL: (B)(6), BATCH: 14966609. TW# (B)(4), PRODUCT FAMILY: SCS-IPG-R, UPN: M365SC11100, MODEL: SC-1110, SERIAL: (B)(6), BATCH: 100012. TW# (B)(4), PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2138500, MODEL: SC-2138-50, SERIAL: (B)(6), BATCH: 107976. TW# (B)(4), PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2138500, MODEL: SC-2138-50, SERIAL: (B)(6), BATCH: A07934. TW# (B)(4), PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2138500, MODEL: SC-2138-50, SERIAL: (B)(6), BATCH: A07678. TW# (B)(4), PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2138500, MODEL: SC-2138-50, SERIAL: (B)(6), BATCH: A06248.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) SYSTEM WAS REPLACED DUE TO IMPLANTABLE PULSE GENERATOR (IPG) CHARGING DIFFICULTIES AND HIGH IMPEDANCES ON THE LEADS. THE PATIENT HAS COVERED ALL HER CHRONIC PAIN AREAS. NEW ALPHA 16 IPG WAS ADDED. DEVICE WILL NOT RETURN DUE TO FACILITY POLICY AND ELECTROCAUTERY WAS USED DURING EXPLANTING THE PRECISION DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1263170 PRECISION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110-02 14966609 08714729767688

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention