BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 8940420 · Received August 28, 2019

    Report

    Report Number
    3006630150-2019-04583
    Event Type
    Injury
    Date Received
    August 28, 2019
    Date of Event
    August 6, 2019
    Report Date
    August 28, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729797807
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-2316-50E, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 5133807, MODEL/CATALOG DESCRIPTION: INFINION 16 TRIAL LEAD KIT 50 CM. THE EXPLANTED DEVICES WAS NOT RETURNED TO BSN AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE LEADS REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT WAS EXPERIENCING DISCOMFORT, SEVERE PAIN AND NUMBNESS OF LEG WAS NOTED POST TRIAL. X-RAY REVEALED NO ANOMALIES. THE PATIENT UNDERWENT A LEAD PULL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736050 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E 5133688 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention