BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION NOVI

    MDR report key: 11215156 · Received January 22, 2021

    Report

    Report Number
    3006630150-2021-00106
    Event Type
    Injury
    Date Received
    January 22, 2021
    Date of Event
    December 30, 2020
    Report Date
    January 22, 2021
    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

    DATE OF EVENT: EXACT DATE UNKNOWN, EVENT OCCURRED SEVEN DAYS AGO FROM THE DATE THE MANUFACTURER WAS MADE AWARE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS-MRI, UPN: (B)(4), MODEL: SC-2408-56, SERIAL: (B)(4), BATCH: 7072097 / 7072183.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AT THE IPG SITE. IT WAS NOTED THAT THE IPG SITE INCISION RUPTURED AFTER IT WAS HIT AGAINST THE DOORWAY. IT WAS BELIEVED THAT THE INFECTION WAS DUE TO THE COLLISION WITH THE IPG SITE AND IT WAS NOT PROCEDURE RELATED. THE PATIENT WAS PLACED ON ANTIBIOTICS. ALL DEVICE COMPONENTS WERE EXPLANTED AND WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112692 PRECISION NOVI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1140 203235 08714729897835

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention