BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION NOVI

    MDR report key: 12108956 · Received July 2, 2021

    Report

    Report Number
    3006630150-2021-03440
    Event Type
    Injury
    Date Received
    July 2, 2021
    Date of Event
    April 1, 2021
    Report Date
    July 2, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729897835
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: EXACT DATE UNKNOWN, EVENT OCCURED IN (B)(6) 2021. EXPLANT DATE: (B)(6) 2021. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2366500, MODEL: SC-2366-50, SERIAL: (B)(4), BATCH: 7071911/7072158.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A NON DEVICE RELATED FALL CAUSING THE BATTERY INCISION SITE TO OPEN. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE. THE EXPLANTED IPG AND LEADS WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1003641 PRECISION NOVI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1140 203992 08714729897835

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention