BEUDAMED
    FDA Adverse Event Death Summary report: N

    FREEDOM NEUROSTIMULATOR

    MDR report key: 10424439 · Received August 19, 2020

    Report

    Report Number
    3010676138-2020-00106
    Event Type
    Death
    Date Received
    August 19, 2020
    Report Date
    July 25, 2020
    Manufacturer
    STIMWAVE TECHNOLOGIES INC.
    Product Code
    GZB
    PMA / PMN Number
    K170141
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE THERAPY SPECIALIST WITNESSED THE ANESTHESIOLOGIST BEGIN INTRAVENOUS SEDATION AND ANTIBIOTIC ADMINISTRATION, AND IMMEDIATELY FOLLOWING THE SEDATION THE PATIENT'S BLOOD PRESSURE DROPPED AND BECAME UNSTABLE. THE ANESTHESIOLOGIST IMMEDIATELY BEGAN TAKING MEASURES TO RE-STABILIZE THE PATIENT. THE THERAPY SPECIALIST REPORTED THAT THE ANESTHESIOLOGIST AND IMPLANTING CLINICIAN DETERMINED THE CASE COULD CONTINUE APPROXIMATELY ONE (1) HOUR AFTER THE PATIENT BECAME UNSTABLE. THE IMPLANTING CLINICIAN PROCEEDED WITH THE CASE AND IMPLANTED BOTH TRIAL STIMULATORS IN APPROXIMATELY FIFTEEN (15) MINUTES, BUT THE DEVICES WERE NEVER TURNED ON. THE THERAPY SPECIALIST LEFT THE OPERATING ROOM AND WAITED FOR APPROXIMATELY ONE (1) HOUR FOR THE PATIENT TO BE BROUGHT BACK TO THE POST PROCEDURE RECOVERY ROOM FOR PROGRAMMING. A NURSE LATER INFORMED THE THERAPY SPECIALIST THAT THE PATIENT WAS TRANSFERRED TO ANOTHER NEARBY HOSPITAL FOR ADDITIONAL MEDICAL ATTENTION. ON THE MORNING OF (B)(6) 2018, THE THERAPY SPECIALIST SPOKE WITH THE PATIENT'S DAUGHTER AND WAS INFORMED THAT THE PATIENT PASSED AWAY THE PREVIOUS NIGHT. THE THERAPY SPECIALIST WITNESSED THE ANESTHESIOLOGIST BEGIN INTRAVENOUS SEDATION AND ANTIBIOTIC ADMINISTRATION, AND IMMEDIATELY FOLLOWING THE SEDATION THE PATIENT'S BLOOD PRESSURE DROPPED AND BECAME UNSTABLE. THE ANESTHESIOLOGIST IMMEDIATELY BEGAN TAKING MEASURES TO RE-STABILIZE THE PATIENT. THE THERAPY SPECIALIST REPORTED THAT THE ANESTHESIOLOGIST AND IMPLANTING CLINICIAN DETERMINED THE CASE COULD CONTINUE APPROXIMATELY ONE (1) HOUR AFTER THE PATIENT BECAME UNSTABLE. THE IMPLANTING CLINICIAN PROCEEDED WITH THE CASE AND IMPLANTED BOTH TRIAL STIMULATORS IN APPROXIMATELY FIFTEEN (15) MINUTES, BUT THE DEVICES WERE NEVER TURNED ON. THE THERAPY SPECIALIST LEFT THE OPERATING ROOM AND WAITED FOR APPROXIMATELY ONE (1) HOUR FOR THE PATIENT TO BE BROUGHT BACK TO THE POST PROCEDURE RECOVERY ROOM FOR PROGRAMMING. A NURSE LATER INFORMED THE THERAPY SPECIALIST THAT THE PATIENT WAS TRANSFERRED TO ANOTHER NEARBY HOSPITAL FOR ADDITIONAL MEDICAL ATTENTION. ON THE MORNING OF (B)(6) 2018, THE THERAPY SPECIALIST SPOKE WITH THE PATIENT'S DAUGHTER AND WAS INFORMED THAT THE PATIENT PASSED AWAY THE PREVIOUS NIGHT. PATIENT DEATH IS UNRELATED TO THE PRODUCT, BASED ON THIS INFORMATION, THE PATIENT DEATH WAS CONFIRMED , THERE IS NO EVIDENCE THAT PRODUCT DID NOT MEET SPECIFICATION AND THE STIMULATOR IS USED FOR TREATMENT OF PAIN. DHR WAS NOT REVIEWED AS THIS WAS NOT ATTRIBUTED TO THE PRODUCT. THE DEVICE WAS NEVER POWERED ON AND WAS NOT IN USE WHEN THE ISSUE OCCURRED.

    Description of Event or Problem · 1

    STIMWAVE QUALITY HAS INVESTIGATED THE DETAILS SURROUNDING A COMPLAINT RESULTING FROM A DEATH NOT RELATED TO DEVICE USE OR MALFUNCTION OF A STIMQ TRIAL PNS STIMULATOR REPORTED ON (B)(6) 2018, BY STIMWAVE THERAPY SPECIALIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889985 FREEDOM NEUROSTIMULATOR SPINAL CORD STIMULATOR GZB STIMWAVE TECHNOLOGIES INC. FR8A-TRL-A0, FR8A-TRL-B0 SWO170822, SWO170822

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Death