BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFINION 16

    MDR report key: 11331670 · Received February 16, 2021

    Report

    Report Number
    3006630150-2021-00487
    Event Type
    Malfunction
    Date Received
    February 16, 2021
    Date of Event
    January 28, 2021
    Report Date
    February 16, 2021
    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

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEAD, UPN: M365SC231650E0, MODEL: SC-2316-50E, SERIAL: (B)(4), BATCH: 7113330.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENTS TRIAL WAS ABORTED DUE TO THE PHYSICIAN HAVING DIFFICULTY PLACING THE LEADS. IT WAS NOTED THAT DURING RETRIEVAL OF THE LEAD IT WAS SHEERED AND A SEGMENT REMAINED INSIDE THE PATIENTS BODY. THE PATIENT WAS DOING WELL POST-OPERATIVELY AND THERE WAS NO PLAN TO REMOVE THE FRAGMENT. LEADS WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230561 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E 7113287 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention