BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERION INDIRECT DECOMPRESSION SYSTEM

    MDR report key: 11735614 · Received April 27, 2021

    Report

    Report Number
    3006630150-2021-01806
    Event Type
    Injury
    Date Received
    April 27, 2021
    Date of Event
    March 12, 2021
    Report Date
    May 27, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NQO
    UDI-DI
    00884662000550
    PMA / PMN Number
    P140004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: SUPERION IMPLANT, UPN: 101-9814, MODEL: 101-9814, SERIAL: N/A, LOT: 800315.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY A MONTH AFTER A SPACER IMPLANT PROCEDURE, THE PATIENT DEVELOPED DEEP VEIN THROMBOSIS (DVT) IN THE RIGHT FEMORAL VEIN AND A SEVERE SADDLE EMBOLISM IN THE UPPER AND LOWER SEGMENTS OF THE RIGHT PULMONARY ARTERY. THE PATIENT WAS HOSPITALIZED, ADMINISTERED ANTICOAGULANTS, AND HAD AN INFERIOR VENA CAVA (IVC) FILTER PLACED TO PREVENT FURTHER PROPAGATION OF THE CLOT. THE PATIENT WAS RELEASED FROM THE HOSPITAL AND WAS BEING FOLLOWED BY HEMATOLOGY. THE PATIENTS FUNCTIONALITY HAS IMPROVED REMARKABLY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE DVT AND SADDLE EMBOLISM WERE ASSESSED AS NOT RELATED TO THE DEVICE OR TO THE IMPLANT PROCEDURE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: UPN: 101-9814, MODEL: 101-9814, SERIAL: N/A, LOT: 800315.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY A MONTH AFTER A SPACER IMPLANT PROCEDURE, THE PATIENT DEVELOPED DEEP VEIN THROMBOSIS (DVT) IN THE RIGHT FEMORAL VEIN AND A SEVERE SADDLE EMBOLISM IN THE UPPER AND LOWER SEGMENTS OF THE RIGHT PULMONARY ARTERY. THE PATIENT WAS HOSPITALIZED, ADMINISTERED ANTICOAGULANTS, AND HAD AN INFERIOR VENA CAVA (IVC) FILTER PLACED TO PREVENT FURTHER PROPAGATION OF THE CLOT. THE PATIENT WAS RELEASED FROM THE HOSPITAL AND WAS BEING FOLLOWED BY HEMATOLOGY. THE PATIENTS FUNCTIONALITY HAS IMPROVED REMARKABLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626322 SUPERION INDIRECT DECOMPRESSION SYSTEM PROSTHESIS, SPINOUS PROCESS SPACER/PLATE NQO BOSTON SCIENTIFIC NEUROMODULATION 101-9814 800256 00884662000550

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| O| R