BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFINION 16

    MDR report key: 16747039 · Received April 14, 2023

    Report

    Report Number
    3006630150-2023-02038
    Event Type
    Injury
    Date Received
    April 14, 2023
    Date of Event
    March 24, 2023
    Report Date
    February 2, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    LGW
    UDI-DI
    08714729797821
    PMA / PMN Number
    P030017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: SCS-LINEAR LEADS, UPN: M365SC2316700, MODEL: SC-2316-70, SERIAL: (B)(4), BATCH: 7081505.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT HAD A NON-DEVICE RELATED FALL TWO DAYS AFTER THE SPINAL CORD STIMULATION (SCS) TRIAL LEAD IMPLANT PROCEDURE. THE FOLLOWING DAY, THE PATIENT EXPERIENCED EXCESSIVE BLEEDING AND PARALYSIS IN BOTH LEGS. THE PATIENT WAS HOSPITALIZED, AND IT WAS FOUND THAT THE PATIENT HAD A HEMATOMA FROM THE LEVEL T9-L2 VERTEBRAE. THE TRIAL LEADS WERE EXPLANTED, AND A LAMINECTOMY AND DECOMPRESSION WERE PERFORMED. THE PHYSICIAN ASSESSED THE EVENT TO BE NOT RELATED TO THE DEVICE OR PROCEDURE, BUT THE RESULT OF THE FALL AND THE FACT THAT THE PATIENT STARTED BLOOD THINNERS ALTHOUGH NOT ADVISED TO DO SO. ADDITIONAL INFORMATION WAS RECEIVED CLARIFYING THE HEMATOMA WAS FROM THE LEVEL T7-L2 VERTEBRAE, AND THE PATIENT EXPERIENCED PARALYSIS FROM THE CHEST DOWN. X-RAY IMAGING WAS DONE TO CHECK FOR BONE FRACTURES. THE PHYSICIAN THAT PERFORMED THE EXPLANT OF THE TRIAL LEADS ASSESSED THAT THE NON-DEVICE RELATED FALL HAD NOT BEEN THE CAUSE OF THE PARALYSIS, BUT INSTEAD, FOUND IT TO BE RELATED TO THE LEADS. THAT PHYSICIAN FURTHER STATED THAT THE PATIENT WAS NOT THE IDEAL CANDIDATE FOR THE TRIAL TO BEGIN WITH DUE TO HIS HIGH RISK FOR BLOOD CLOTS. THE PREVIOUS ASSESSMENT OF THE EVENT WAS PROVIDED BY THE IMPLANTING PHYSICIAN.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT HAD A NON-DEVICE RELATED FALL TWO DAYS AFTER THE SPINAL CORD STIMULATION (SCS) TRIAL LEAD IMPLANT PROCEDURE. THE FOLLOWING DAY, THE PATIENT EXPERIENCED EXCESSIVE BLEEDING AND PARALYSIS IN BOTH LEGS. THE PATIENT WAS HOSPITALIZED, AND IT WAS FOUND THAT THE PATIENT HAD A HEMATOMA FROM THE LEVEL T9-L2 VERTEBRAE. THE TRIAL LEADS WERE EXPLANTED, AND A LAMINECTOMY AND DECOMPRESSION WERE PERFORMED. THE PHYSICIAN ASSESSED THE EVENT TO BE NOT RELATED TO THE DEVICE OR PROCEDURE, BUT THE RESULT OF THE FALL AND THE FACT THAT THE PATIENT STARTED BLOOD THINNERS ALTHOUGH NOT ADVISED TO DO SO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2319523 INFINION 16 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW BOSTON SCIENTIFIC NEUROMODULATION SC-2316-70 7081417 08714729797821

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Disability| H