BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION NOVI

    MDR report key: 10332453 · Received July 28, 2020

    Report

    Report Number
    3006630150-2020-03115
    Event Type
    Injury
    Date Received
    July 28, 2020
    Date of Event
    January 8, 2020
    Report Date
    July 28, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729897835
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS- LINEAR LEADS: UPN: (B)(4), MODEL: SC-2352-50, SERIAL: (B)(4), BATCH: 7070232/7070326.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A NON-DEVICE RELATED FALL WHICH CAUSED THE IPG TO MIGRATE. IT WAS ALSO NOTED THAT THE PATIENT WAS EXPERIENCING EXTREME PAIN AND WAS HAVING A STITCH SUPERFICIAL TO THE SKIN SITE THAT CAME OUT. ALL DEVICES WERE EXPLANTED AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    800024 PRECISION NOVI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1140 202071 08714729897835

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention