BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 9547835 · Received January 3, 2020

    Report

    Report Number
    3006630150-2019-07794
    Event Type
    Injury
    Date Received
    January 3, 2020
    Date of Event
    December 14, 2019
    Report Date
    January 3, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729797807
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/ CATALOG NUMBER: SC-2316-50E, SERIAL NUMBER: (B)(4), BATCH/ LOT NUMBER: 7072859, MODEL/ CATALOG DESCRIPTION: INFINION 16 TRIAL LEAD KIT 50 CM. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. IT IS INDICATED THAT THE DEVICES WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICES COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MED WATCH WILL BE FILED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT FOLLOWING A TRIAL PROCEDURE, THE PATIENT WAS EXPERIENCING PAIN, NAUSEA, HEADACHE AND FEVER. THE PATIENT WENT TO THE EMERGENCY ROOM (ER) PER PHYSICIANS INSTRUCTION. IT WAS DETERMINED THAT THE PATIENT HAD NO FEVER AND COMPUTED TOMOGRAPHY (CT) SCAN AS WELL AS BLOOD WORK REVEALED NEGATIVE RESULTS. THE PHYSICIAN BELIEVED THAT THIS WAS NOT DEVICE RELATED. IT WAS ALSO NOTED THAT NOTHING HAPPENED DURING THE TRIAL THAT WOULD CAUSE THE SYMPTOMS. THE PATIENT UNDERWENT AN EARLY LEAD PULL PROCEDURE AND WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8612 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E 5171196 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention