BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINION 16

    MDR report key: 15615880 · Received October 17, 2022

    Report

    Report Number
    3006630150-2022-05566
    Event Type
    Malfunction
    Date Received
    October 17, 2022
    Date of Event
    September 27, 2022
    Report Date
    October 17, 2022
    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
    CT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS. UPN: M365SC231650E0. MODEL: SC-2316-50E. SERIAL: (B)(4). BATCH: 7173451.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PATIENTS TRIAL PROCEDURE, THE PHYSICIAN WAS HAVING DIFFICULTY PLACING THE SECOND LEAD DUE TO PATIENTS SCOLIOSIS. THE PHYSICIAN DECIDED TO REMOVE THE LEAD AND UPON REMOVAL OF THE LEAD AS WELL AS THE NEEDLE, THE TIP OF THE LEAD BROKE OFF AND TWO CONTACTS WERE LEFT IN THE PATIENTS BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2224725 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E 7172934 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male Required Intervention