BEUDAMED
    FDA Adverse Event Death Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 7682347 · Received July 12, 2018

    Report

    Report Number
    1723170-2018-02964
    Event Type
    Death
    Date Received
    July 12, 2018
    Date of Event
    January 10, 2018
    Report Date
    July 12, 2018
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    HAW
    UDI-DI
    00613994450944
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THESE EVENTS WERE REPORTED IN LITERATURE ARTICLE: STRAUSS, IDO; BERGER, ASSAF; ARAD, MICHAL; HOCHBERG, URI. "O-ARM-GUIDED PERCUTANEOUS RADIOFREQUENCY CORDOTOMY." STEROTACTIC AND FUNCTIONAL NEUROSURGERY, 95, 2017: 409-416. PATIENT INFORMATION WAS UNAVAILABLE FROM THE SITE. THE AGE PROVIDED WAS THE MEAN OF THE ALL THE PATIENTS INVOLVED IN THE LITERATURE. THE GENDER PROVIDED IS THE GENDER OF THE MAJORITY OF THE PATIENTS. PLEASE NOTE THAT THE ACTUAL DATE OF DEATH WAS NOT PROVIDED IN THE LITERATURE ARTICLE; THIS DATE IS BASED ON THE DATE OF ARTICLE PUBLICATION. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. PART NOT RETURNED.

    Description of Event or Problem · 1

    BACKGROUND: PAIN IS OFTEN ONE OF THE MOST DEBILITATING SYMPTOMS IN PATIENTS WITH ADVANCED ONCOLOGICAL DISEASE. PATIENTS WITH LOCALIZED PAIN DUE TO MALIGNANCY REFRACTORY TO MEDICAL TREATMENT CAN BENEFIT FROM SELECTIVE PERCUTANEOUS CORDOTOMY THAT DISCONNECTS THE ASCENDING PAIN FIBERS IN THE SPINOTHALAMIC TRACT. OBJECTIVES: OVER THE PAST YEAR, WE HAVE BEEN PERFORMING PERCUTANEOUS RADIOFREQUENCY CORDOTOMY WITH THE USE OF THE O-ARM INTRAOPERATIVE IMAGING SYSTEM THAT ALLOWS BOTH 2D FLUOROSCOPY AND 3D RECONSTRUCTED COMPUTERIZED TOMOGRAPHY IMAGING. WE PRESENT OUR EXPERIENCE USING THIS TECHNIQUE, FOCUSING ON TECHNICAL NUANCES AND COMPLICATIONS. METHODS: A RETROSPECTIVE ANALYSIS WAS CONDUCTED OF ALL PATIENTS WHO UNDERWENT PERCUTANEOUS CORDOTOMY BETWEEN MARCH 2016 AND MARCH 2017. RESULTS: NINETEEN PATIENTS UNDERWENT PERCUTANEOUS CORDOTOMY PROCEDURES. TWO PATIENTS DEVELOPED INTRAOPERATIVE DELIRIUM AND WERE UNABLE TO TOLERATE THE PROCEDURE. IN 16 OUT OF 17 COMPLETED PROCEDURES, WE ACHIEVED EXCELLENT IMMEDIATE PAIN RELIEF (94%). AT 1 MONTH AFTER OPERATION, 15 OF THE 17 (88%) PATIENTS WERE PAIN FREE, AND AT 3 MONTHS 5 OUT OF 5 PATIENTS AVAILABLE FOR FOLLOW-UP WERE STILL FREE OF THEIR ORIGINAL PAIN. MIRROR PAIN DEVELOPED IN 6 OF THE 17 PATIENTS (35%), BUT WAS MILD IN 4 OF THESE CASES AND CONTROLLED WITH MEDICATIONS. WE EXPERIENCED 1 SERIOUS COMPLICATION (6%) OF IPSILATERAL HEMIPARESIS. CONCLUSION: PERCUTANEOUS CORDOTOMY USING THE OARM IS SAFE AND EFFECTIVE IN THE TREATMENT OF INTRACTABLE ONCOLOGICAL PAIN. REPORTED EVENTS: (B)(6) FEMALE WITH MILD MIRROR PAIN CONTROLLED WITH MEDICATION, DECEASED AFTER ONE MONTH FOLLOWING CORDOTOMY. (B)(6) MALE WITH MILD MIRROR PAIN CONTROLLED WITH MEDICATION, DECEASED AFTER 2 MONTHS FOLLOWING CORDOTOMY. (B)(6) MALE WITH HEADACHES, DECEASED AFTER 5 MONTHS FOLLOWING CORDOTOMY. (B)(6) MALE DECEASED AFTER 3 MONTHS FOLLOWING CORDOTOMY. (B)(6) FEMALE DECEASED AFTER 2 MONTHS FOLLOWING CORDOTOMY. (B)(6) FEMALE DECEASED AFTER 2 MONTHS FOLLOWING CORDOTOMY. (B)(6) FEMALE DECEASED AFTER 2 MONTHS FOLLOWING CORDOTOMY. (B)(6) FEMALE DECEASED AFTER 1 MONTH FOLLOWING CORDOTOMY. (B)(6) MALE DECEASED AFTER 1 MONTH FOLLOWING CORDOTOMY. (B)(6) FEMALE DECEASED AFTER 1 MONTH FOLLOWING CORDOTOMY. (B)(6) MALE DECEASED AFTER 1 MONTH FOLLOWING CORDOTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525044 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. (LOUISVILLE) S7 00613994450944

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death