BEUDAMED
    FDA Adverse Event Death Summary report: N

    FREEDOM SPINAL CORD STIMULATOR

    MDR report key: 9355122 · Received November 21, 2019

    Report

    Report Number
    3010676138-2019-00051
    Event Type
    Death
    Date Received
    November 21, 2019
    Report Date
    November 21, 2019
    Manufacturer
    STIMWAVE TECHNOLOGIES INC.
    Product Code
    GZB
    UDI-DI
    00859619004875
    PMA / PMN Number
    K162161
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    IMMEDIATELY FOLLOWING NOTIFICATION, STIMWAVE QUALITY REVIEWED EVENTS PRECEDING THE ISSUE. THE PATIENT HAD A TRIAL PROCEDURE PERFORMED ON (B)(6) 2016, IN WHICH ONE (1) FREEDOM-8A RECEIVER STIMULATOR (FR8A-RCV-A0) AND ONE (1) SPARE LEAD (FR8A-SPR-B0) WERE IMPLANTED BILATERALLY AT THE T8-T9 VERTEBRAL LEVEL. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. ON OCTOBER 25, 2019, STIMWAVE WAS NOTIFIED THE PATIENT HAD PASSED AWAY (EXACT DATE UNKNOWN). INFORMATION RECEIVED ATTRIBUTED THE DEATH TO A DRUG OVERDOSE. THE EVENT WAS NOT RELATED TO THE DEVICE. AT THE TIME OF THE PATIENT'S DEATH, THE DEVICE WAS NO LONGER IN USE AND HAD ALREADY BEEN EXPLANTED. THERE IS NO INDICATION THE DEVICE COULD HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH. THE DEVICE WAS NOT IMPLANTED AT THE TIME OF THE EVENT. THE ROOT CAUSE OF THE COMPLAINT IS NOT ATTRIBUTED TO DEVICE FAILURE, THE INABILITY OF THE DEVICE TO MEET PERFORMANCE OR SAFETY SPECIFICATIONS, OR NONCONFORMANCE TO PHYSICAL OR FUNCTIONAL DEVICE SPECIFICATIONS. THE STIMWAVE PRODUCT WAS NOT THE SOURCE OF THE ISSUE. THE DEVICE WAS NO LONGER IN USE AT THE TIME OF THE PATIENT'S DEATH. THE EVENT WAS RELATED TO UNKNOWN PATIENT COMORBIDITIES. CORRECTIVE ACTION IS NOT REQUIRED TO REMEDY THE ROOT CAUSE OF THE COMPLAINT. THE DEVICE DID NOT FAIL TO MEET PERFORMANCE OR SAFETY SPECIFICATIONS. THE PATIENT'S DEATH WAS NOT RELATED TO THE DEVICE. STIMWAVE CONFIRMED THAT THE PRODUCT DID NOT FAIL TO MEET PERFORMANCE AND SAFETY SPECIFICATIONS. THE SOURCE OF WAS RELATED TO UNKNOWN PATIENT COMORBIDITES. STIMWAVE HAS INFORMED ALL PARTIES THAT THE PRODUCT WAS NOT THE SOURCE ISSUE. IN COMPLIANCE WITH MEDICAL DEVICE REPORTING REQUIREMENTS AND RESPONSIBILITIES, STIMWAVE QUALITY AND ITS CHIEF MEDICAL OFFICER HAVE DETERMINED THAT THIS ISSUE IS CONSIDERED REPORTABLE, AS THE EVENT RESULTED IN A DEATH. THIS EVENT HAS BEEN REPORTED TO THE UNITED STATES FOOD AND DRUG ADMINISTRATION (FDA) ON NOVEMBER 21, 2019.

    Description of Event or Problem · 1

    STIMWAVE QUALITY HAS INVESTIGATED THE DETAILS REGARDING A COMPLAINT RESULTING FROM A PATIENT DEATH, UNRELATED TO THE DEVICE, REPORTED TO STIMWAVE ON OCTOBER 25, 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1149014 FREEDOM SPINAL CORD STIMULATOR SPINAL CORD STIMULATOR GZB STIMWAVE TECHNOLOGIES INC. FR8A-RCV-A0, FR8A-RCV-B0 SWL160705A, SWL160705B 00859619004875

    Patients

    Seq Age Sex Outcome Treatment
    1 Death