BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 11690993 · Received April 19, 2021

    Report

    Report Number
    3006630150-2021-01652
    Event Type
    Injury
    Date Received
    April 19, 2021
    Date of Event
    February 26, 2021
    Report Date
    April 19, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729797807
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: (B)(4), MODEL: SC-2316-50E, SERIAL: (B)(4), BATCH: 7113842.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE LEAD PULL PROCEDURE, THE PATIENT HAD SEVERE PAIN AT THE NECK, BACK AND CHEST. THE PATIENT WAS SENT FOR A MAGNETIC RESONANCE IMAGING (MRI), BUT THE PATIENT REFUSED AND WAS NON-COMPLIANT. THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM WHEREIN IT WAS DETERMINED THAT THERE WAS NO PROBLEM SUSPECTED AT FIRST AND THE PHYSICIAN BELIEVED THAT THE PATIENT WAS HAVING MANIC EPISODE. IT WAS ALSO THEN REPORTED THAT THE PATIENT HAD AN EPIDURAL BLEED WHICH WAS UNCLEAR IF IT WAS RELATED TO THE LEAD PULL PROCEDURE. THE PATIENT WAS PUT INTO THE HOSPITAL FOR OBSERVATION. THE REMOVED LEADS WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581306 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E 7109069 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R