BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 10236291 · Received July 6, 2020

    Report

    Report Number
    3006630150-2020-02768
    Event Type
    Injury
    Date Received
    July 6, 2020
    Date of Event
    June 13, 2020
    Report Date
    July 6, 2020
    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
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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: (B)(4), MODEL:SC-2316-50E, SERIAL: (B)(4), BATCH: 7092081.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A TIGHT BAND AND MILD DISCOMFORT UNDER THE SHOULDER BLADES AND IN THE LEFT RIBS. IT WAS ALSO STATED THAT THE RIB DISCOMFORT WORSENED DUE TO A CHANGE IN THE STIMULATION COVERAGE AREA FROM THE LEFT LEG TO THE LEFT RIB CAGE. THE PATIENT HAD A REPROGRAMMING HOWEVER, THE PAIN AREAS WERE NOT CAPTURED. THE PATIENT UNDERWENT A LEAD PULL. THE PHYSICIAN NOTED THAT THE PATIENTS SYMPTOMS WERE CAUSED BY SPINAL STENOSIS AND THAT THE LEADS MIGRATED LATERALLY WHICH MADE THE RIB DISCOMFORT WORSE. THE PATIENT WAS DOING WELL POSTOPERATIVELY AS THE SYMPTOMS IMPROVED AFTER THE PROCEDURE. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701804 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E 7091057 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention