BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 10167853 · Received June 18, 2020

    Report

    Report Number
    3006630150-2020-02516
    Event Type
    Injury
    Date Received
    June 18, 2020
    Date of Event
    June 2, 2020
    Report Date
    June 18, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729797807
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS: UPN: (B)(4), MODEL: SC-2316-50E, SERIAL: (B)(4), BATCH: 7092229.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING OVERSTIMULATION WHEN CHANGING POSTURES AND THAT THE PATIENT HAD PAIN AND DID NOT RECEIVE ADEQUATE STIMULATION DUE TO LEADS THAT WERE PULLED DOWN FROM ITS ORIGINAL POSITION WHICH WAS CONFIRMED THROUGH X-RAY. THE PHYSICIAN CONFIRMED WITH PATIENT THAT THE COVERAGE WERE GREAT BEFORE THE LEADS MIGRATED. THE LEADS WERE PULLED OUT AND DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632749 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E 7092190 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention