BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 8911478 · Received August 20, 2019

    Report

    Report Number
    3006630150-2019-04423
    Event Type
    Injury
    Date Received
    August 20, 2019
    Date of Event
    August 1, 2019
    Report Date
    August 20, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729797807
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-2316-50E, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 5162613, 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. 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 AN HOUR AFTER A TRIAL PROCEDURE, THE PATIENT WAS UNABLE TO STAND DUE TO WEAKNESS. MAGNETIC RESONANCE IMAGING REVEALED THAT THE PATIENT HAD SWELLING AT THE LEAD SITE AND CONTUSION ON THE SPINAL CORD. THE PATIENT'S SYMPTOMS WERE NOT PROCEDURE RELATED BUT IT WAS UNKNOWN IF IT WERE DEVICE RELATED. THE PATIENT UNDERWENT AN EARLY LEAD PULL PROCEDURE AND WAS SENT TO REHABILITATION FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702724 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E 5161541 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention