BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION NOVI

    MDR report key: 11496385 · Received March 16, 2021

    Report

    Report Number
    3006630150-2021-00997
    Event Type
    Injury
    Date Received
    March 16, 2021
    Date of Event
    February 7, 2021
    Report Date
    April 20, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729897835
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). SN: (B)(6). THE RETURNED IPG WAS ANALYZED AND THE MONITORED STIMULATION ON AN OSCILLOSCOPE FOUND THE OUTPUTS WERE CONSISTENT AND CORRECT ON ALL ELECTRODES. CURRENT LEAKAGE TESTS AND RESIDUAL GAS ANALYSIS VERIFIED NO LOSS OF ELECTRIC CURRENT INTO THE SURROUNDING TISSUE. IT PASSED THE FUNCTIONAL TEST AND REVEALED NO ANOMALIES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING TIGHTNESS AND SPASMS IN THE NECK AND DISCOMFORT IN THE IPG SITE. IT WAS ALSO NOTED THAT THE TIGHTNESS AND SPASMS IN THE NECK WAS COMING FROM THE PROCEDURAL RECOVERY BUT IT WENT AWAY AFTER ABOUT A WEEK. THE PATIENT UNDERWENT AN IPG EXPLANT PROCEDURE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2352700, MODEL: SC-2352-70, SERIAL: (B)(4), BATCH: 7070579 / 7071375.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING TIGHTNESS AND SPASMS IN THE NECK AND DISCOMFORT IN THE IPG SITE. IT WAS ALSO NOTED THAT THE TIGHTNESS AND SPASMS IN THE NECK WAS COMING FROM THE PROCEDURAL RECOVERY BUT IT WENT AWAY AFTER ABOUT A WEEK. THE PATIENT UNDERWENT AN IPG EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395071 PRECISION NOVI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-1140 203737 08714729897835

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention