BEUDAMED
    FDA Adverse Event Death Summary report: N

    INFINION 16

    MDR report key: 19337084 · Received May 16, 2024

    Report

    Report Number
    3006630150-2024-03156
    Event Type
    Death
    Date Received
    May 16, 2024
    Date of Event
    April 20, 2024
    Report Date
    May 16, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729797807
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT (S) INVOLVED IN THE EVENT: PRODUCT FAMILY: INFINION 16. UPN: M365SC231650E0. MODEL: SC-2316-50E. SERIAL:(B)(6). BATCH: 7240986.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PASSED AWAY FOUR DAYS AFTER THE IMPLANT OF THE SPINAL CORD STIMULATOR (SCS) TRIAL LEADS. IT IS NOT KNOWN WHAT CAUSED THE PATIENTS' DEATH, HOWEVER THE PHYSICIAN ASSESSED IT WAS NOT DEVICE RELATED, AND THAT NOTHING OCCURRED DURING THE PROCEDURE THAT MAY HAVE CAUSED THE PATIENTS' DEATH. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380575 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E 7218434 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Male Death