BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 10858832 · Received November 18, 2020

    Report

    Report Number
    3006630150-2020-05630
    Event Type
    Injury
    Date Received
    November 18, 2020
    Date of Event
    October 27, 2020
    Report Date
    November 18, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729837145
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS; UPN: M365SC231670E0; MODEL: SC-2316-70E; SERIAL: (B)(4); BATCH: 7072119.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING THE TRIAL PROCEDURE, THE PATIENT WAS EXPERIENCING UNBEARABLE PAIN AND WEAKNESS IN THE LEGS. UPON INVESTIGATION, THE PHYSICIAN NOTED THAT THE PATIENT WAS EXPERIENCING EPIDURAL HEMATOMA FROM THE NEEDLE PLACEMENT. IT WAS ALSO STATED THAT THE PATIENTS ISSUES WERE NOT DEVICE RELATED BUT WAS DUE TO THE PROCEDURE. THE PATIENT HAD A LEAD PULL PROCEDURE AND THE PATIENT WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1324607 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-70E 7071773 08714729837145

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention