BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 9284165 · Received November 6, 2019

    Report

    Report Number
    3006630150-2019-06277
    Event Type
    Injury
    Date Received
    November 6, 2019
    Date of Event
    October 21, 2019
    Report Date
    November 6, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729797807
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-2316-50E, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 7052978, MODEL/CATALOG DESCRIPTION: INFINION 16 TRIAL LEAD KIT 50 CM. THE EXPLANTED DEVICES WER 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 THE MANUFACTURING.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT FOLLOWING A TRIAL PROCEDURE, THE PATIENT DEVELOPED AN INVOLUNTARY TWITCHING IN THE LEFT LEG. THE INVOLUNTARY TWITCHING REMAINED AFTER THE LEFT LEAD WAS REMOVED. THE PHYSICIAN OPTED TO REMOVE THE RIGHT LEAD AS WELL AND THE SYMPTOMS CEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1082595 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E 5153247 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention