BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 8150994 · Received December 11, 2018

    Report

    Report Number
    3006630150-2018-62193
    Event Type
    Injury
    Date Received
    December 11, 2018
    Date of Event
    November 26, 2018
    Report Date
    December 11, 2018
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729797807
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-2316-50E, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 5093647, 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.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING SEVERE PAIN AFTER TRIAL PROCEDURE. THE PHYSICIAN PULLED THE LEADS AND IMMEDIATELY ORDERED MAGNETIC RESONANCE IMAGING (MRI) TO CHECK FOR HEMATOMA. A HEMATOMA WAS FOUND IN THE SPINAL CANAL AND THE PATIENT HAD EMERGENCY SURGERY TO REMOVE OR DRAIN THE HEMATOMA. THE PATIENT WAS IN STABLE CONDITION AND THE PAIN HAS SUBSIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    992662 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E 5092398 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention