BEUDAMED
    FDA Adverse Event Death Summary report: N

    INFINION 16

    MDR report key: 18013194 · Received October 26, 2023

    Report

    Report Number
    3006630150-2023-06558
    Event Type
    Death
    Date Received
    October 26, 2023
    Date of Event
    September 27, 2023
    Report Date
    October 26, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729797807
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC231650E0, MODEL: SC-2316-50E, SERIAL: (B)(6), BATCH: 7203674.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ONE OF THE TRIAL LEADS WAS INCORRECTLY PLACED IN THE INTRATHECAL SPACE, AND IT WAS DECIDED TO LEAVE BOTH LEADS IN AND ONLY PROGRAM THE LEAD THAT WAS POSTERIOR. FOLLOWING THE LEAD PULL PROCEDURE, THE PATIENT DEVELOPED A HEADACHE AS A RESULT OF CEREBROSPINAL FLUID (CSF) LEAKAGE SECONDARY TO PLACEMENT OF THE LEAD. THE PATIENT WAS BROUGHT IN FOR A BLOOD PATCH, HOWEVER, BECAME UNRESPONSIVE AFTER AND WAS THEN PLACED IN THE INTENSIVE CARE UNIT (ICU). THE PATIENT WAS ALSO PUT ON A VENTILATOR DUE TO A BLOOD INFECTION. THE PATIENT LATER PASSED AWAY. THE CAUSE OF INFECTION WAS UNKNOWN, AND IT WAS ALSO UNCLEAR IF THE STATUS OF THE PATIENT WAS DIRECTLY RELATED TO THE TRIAL PROCEDURE AS THE PATIENTS ALTERED STATE DID NOT OCCUR UNTIL AFTER THE BLOOD PATCH. THE TRIAL LEADS WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1674145 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-50E 7200179 08714729797807

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Death| H| R