BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION NOVI

    MDR report key: 20094466 · Received August 29, 2024

    Report

    Report Number
    3006630150-2024-05717
    Event Type
    Injury
    Date Received
    August 29, 2024
    Date of Event
    August 9, 2024
    Report Date
    September 26, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729897835
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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-PC, UPN: M365SC11400, MODEL: SC-1140, SERIAL: (B)(6), BATCH: 203659.

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL SUBMITTED TO INCLUDE ADDITIONAL INFORMATION RECEIVED FROM BOSTON SCIENTIFIC SALES REPRESENTATIVE THAT CHANGED FIELDS B5 AND F10. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: TW# (B)(4). PRODUCT FAMILY: SCS-IPG-PC. UPN: M365SC11400. MODEL: SC-1140. SERIAL: (B)(6). BATCH: 203659.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) SYSTEM WAS REPLACED DUE TO AN UNKNOWN REASON. THE LOCATION OF THE DEVICES IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS SPINAL CORD STIMULATION (SCS) SYSTEM WAS REPLACED DUE TO AN ELECTIVE IMPLANTABLE PULSE GENERATOR (IPG) UPGRADE TO BE MAGNETIC RESONANCE IMAGING (MRI) COMPATIBLE. THE PATIENT IS DOING FINE POSTOPERATIVELY AND HAPPY WITH NEW PROGRAMS. DEVICE WILL NOT RETURN DUE TO FACILITY POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1314656 PRECISION NOVI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1140 203659 08714729897835

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention