BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINION 16

    MDR report key: 18053765 · Received November 2, 2023

    Report

    Report Number
    3006630150-2023-06727
    Event Type
    Malfunction
    Date Received
    November 2, 2023
    Date of Event
    October 11, 2023
    Report Date
    January 4, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729797807
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Product Problem
    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: M365SC231650E0. MODEL: SC-2316-50E. SERIAL: (B)(6). BATCH: 7210006.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THAT THE PATIENT UNDERWENT A LEAD PULL AND FOUR ELECTRODES APPEARED TO BE LEFT IN PATIENTS BODY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEAD PULL AND FOUR ELECTRODES APPEARED TO BE LEFT IN PATIENTS BODY. ADDITIONAL INFORMATION WAS RECEIVED THAT REMAINING CONTACTS WERE REMOVED DURING PATIENTS IMPLANT PROCEDURE. THE PATIENT WAS REPORTEDLY DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1890151 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E 7209955 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Male Other