BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 10044440 · Received May 11, 2020

    Report

    Report Number
    3006630150-2020-02031
    Event Type
    Injury
    Date Received
    May 11, 2020
    Date of Event
    March 30, 2020
    Report Date
    May 11, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729797807
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MODEL NUMBER/CATALOG NUMBER: SC-2316-50E, SERIAL NUMBER: (B)(4), BATCH/LOT NUMBER: 7090162, 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.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT HAD A SUSPECTED INFECTION AND WAS EXPERIENCING INCREASED LOW BACK PAIN AND MUSCLE SPASMS AFTER A LEAD PULL. A LUMBAR MRI WAS TAKEN AND REVEALED EPIDURAL ABSCESS. THE PHYSICIAN DOES NOT BELIEVE THAT THE INFECTION WAS DEVICE NOR PROCEDURE RELATED. THE PATIENT WAS PLACED ON ANTIBIOTICS AND WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506380 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E 7089408 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention