BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 14316925 · Received May 7, 2022

    Report

    Report Number
    3006630150-2022-02088
    Event Type
    Injury
    Date Received
    May 7, 2022
    Date of Event
    April 11, 2022
    Report Date
    May 6, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729797807
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: 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: M365SC231650E0; MODEL: SC-2316-50E; SERIAL: (B)(4); BATCH: 7150268.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PHYSICIAN WAS UNAWARE WHEN OR WHERE THE TRIAL PATIENT DID THE LEAD PULL. THE PATIENT WAS BROUGHT TO THE HOSPITAL FOR COMPLICATIONS. THE TRIAL LEADS WERE KEPT BY THE HOSPITAL AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1078077 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E 7147038 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Required Intervention