BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION

    MDR report key: 19441251 · Received May 31, 2024

    Report

    Report Number
    3006630150-2024-03533
    Event Type
    Injury
    Date Received
    May 31, 2024
    Date of Event
    August 7, 2008
    Report Date
    May 31, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS UPN: M365SC2208500 MODEL: SC-2208-50 SERIAL: (B)(6) BATCH: 170727/172078.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING CRAMPING-LIKE SENSATIONS IN THE ABDOMEN WHICH BELIEVED TO BE CAUSED BY STIMULATION. THE PATIENT HAD STEROID INJECTION AND WAS DOING WELL WITH FAVORABLE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307408 PRECISION STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1110 171918

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Required Intervention