BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION SPECTRA

    MDR report key: 20224183 · Received September 16, 2024

    Report

    Report Number
    3006630150-2024-06151
    Event Type
    Injury
    Date Received
    September 16, 2024
    Date of Event
    August 19, 2024
    Report Date
    September 16, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729821526
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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: M365SC11320, MODEL: SC-1132, SERIAL: (B)(6), BATCH: 16099553. TW# (B)(4), PRODUCT FAMILY: SCS-IPG-R, UPN: M365SC11600, MODEL: SC-1160, SERIAL: (B)(6), BATCH: 352499.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) SYSTEM WAS REPLACED DUE TO THE PATIENT EXPERIENCING SHORTER BATTERY LIFE AND THEN DIFFICULTY CHARGING. THE PATIENT IS FULLY RECOVERED. DEVICE WILL NOT RETURN DUE TO FACILITY POLICY AND ELECTROCAUTERY WAS USED DURING EXPOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1106361 PRECISION SPECTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1132 16099553 08714729821526

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R