BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 11698078 · Received April 20, 2021

    Report

    Report Number
    3006630150-2021-01687
    Event Type
    Injury
    Date Received
    April 20, 2021
    Date of Event
    March 25, 2021
    Report Date
    April 20, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729797821
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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: 7082858.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING SPINAL CORD STIMULATOR (SCS) TRIAL PROCEDURE, THE PATIENT FELT DISCOMFORT. THE PHYSICIAN ASSESSED THAT THE PATIENT DEVELOPED A HEMATOMA WITHIN THE EPIDURAL SPACE. THE TRIAL LEADS WERE REMOVED AND THE HEMATOMA WAS TREATED SURGICALLY. THE PATIENT WAS HOSPITALIZED FOR RECOVERY AND OBSERVATION. PATIENT STATUS IS GOOD AND THE PHYSICIAN REPORTS NO LASTING NEGATIVE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589966 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-70 7070145 08714729797821

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention