BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 17122458 · Received June 13, 2023

    Report

    Report Number
    3006630150-2023-03368
    Event Type
    Injury
    Date Received
    June 13, 2023
    Date of Event
    May 19, 2023
    Report Date
    July 6, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729837145
    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

    BLOCK B3: 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: M365SC231670E0. MODEL: SC-2316-70E. SERIAL: (B)(4). BATCH: 7082077.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS HAVING TOO MUCH PROCEDURAL PAIN. THE PATIENTS LEADS WERE PULLED. THE LEADS WILL NOT BE RETURNED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAD AN EARLY LEAD PULL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS HAVING TOO MUCH PROCEDURAL PAIN. THE PATIENTS LEADS WERE PULLED. THE LEADS WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1850386 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-70E 7082027 08714729837145

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Required Intervention