BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION NOVI

    MDR report key: 10711568 · Received October 21, 2020

    Report

    Report Number
    3006630150-2020-05044
    Event Type
    Injury
    Date Received
    October 21, 2020
    Date of Event
    August 25, 2020
    Report Date
    October 21, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729897835
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE, UPN: (B)(4), MODEL: SC-2352-50, SERIAL: (B)(4), BATCH: 5105277 / 5132876.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING PAIN AT THE IPG SITE. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. ALL DEVICE COMPONENTS WERE EXPLANTED AND WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1178576 PRECISION NOVI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1140 21509900 08714729897835

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention