BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINALPAK ASSEMBLY

    MDR report key: 11543681 · Received March 22, 2021

    Report

    Report Number
    0002242816-2021-00031
    Event Type
    Injury
    Date Received
    March 22, 2021
    Date of Event
    February 20, 2021
    Report Date
    June 18, 2024
    Manufacturer
    EBI, LLC.
    Product Code
    LOF
    UDI-DI
    00812301020225
    PMA / PMN Number
    P850022
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTIONS IN B4: DATE OF THE REPORT, B5: EVENT DESCRIPTION, D3: MANUFACTURER, D4: UDI, G1: CONTACT OFFICE, G6: TYPE OF REPORT, H2, AND H3. ADDITIONAL INFORMATION IN D8-9, G3, H4: DEVICE MANUFACTURE DATE, H6: PATIENT CODE, DEVICE CODE, IMPACT CODE, METHOD, AND RESULTS, AND H10: ADDITIONAL NARRATIVE INVESTIGATION SUMMARY THE SPINALPAK ASSEMBLY WAS RECEIVED FOR EVALUATION BUT DUE TO THE NATURE OF THE COMPLAINT AND THE INFORMATION PROVIDED WITHIN THE COMPLAINT FILE, ONLY THE SPINALPAK STIMULATOR WAS EVALUATED. A VISUAL INSPECTION OF THE CUSTOMER RETURNED PRODUCT WAS PERFORMED. INCLUDED WAS ONE SPINALPAK STIMULATOR PART NO. 1067717 WITH SERIAL NUMBER (B)(6) RECEIVED IN A SHIPPING BOX. THE PART RECEIVED LOOKS TO BE IN GOOD CONDITION FROM THE VISUAL/COSMETIC POINT OF VIEW. THE DHR HAS INDICATED NO REPORTED NON-CONFORMANCES OR DEVIATIONS. THE SPINALPAK STIMULATOR COMPLIANCE DATA WAS DOWNLOADED ON JUN 18, 2024. THE COMPLIANCE DATA INDICATES THE UNIT TREATED FOR 2 DAYS 14 HOURS AND 32 MINUTES. THE CLOCK LIFETIME OF THE SPINALPAK STIMULATOR WAS 1208 DAYS. THE CONTROLLER AUTOMATICALLY ENTERS ¿END OF LIFETIME MODE¿ AFTER 270 DAYS AS PER DSD-00173 REVISION A AND DSD-00116-SRS (7900032) REVISION E. AT THE TIME OF THE COMPLAINT, THE UNIT WAS NOT AT ENDPOINT. THE SPINALPAK STIMULATOR WAS RESET IN ORDER TO PERFORM THE BURN IN TEST. THE SP UNIT RAN BURN-IN STAND-ALONE ¿BATTERY¿ ONLY FOR MORE THAN 24 HOURS WITH NO PROBLEM. THE MEASURED OUTPUT PERIOD WAS 16.05 USEC (SPECIFICATION - OUTPUT PERIOD FROM 15.2USEC ¿ 18.5USEC) ¿¿PASS¿. THE MEASURED OUTPUT AMPLITUDE WAS 5.6 VPP (SPECIFICATION - OUTPUT AMPLITUDE FROM 5.4VPP ¿ 6.4VPP) ¿¿PASS". ALL TESTS/INSPECTIONS WERE COMPLETED USING TEKTRONIX OSCILLOSCOPE ID OS-C001066 WITH CALIBRATION DUE ON APRIL 23, 2025; AND TF1930 S/N (B)(6) WITH A CALIBRATION DUE DATE OF FEBRUARY 15, 2025. TEST/INSPECTIONS WERE COMPLETED BY THE QUALITY DEPARTMENT ON JUNE 18, 2024. REVIEW OF THE INFORMATION PROVIDED BY THE CUSTOMER AND THE FINDINGS FROM THE INVESTIGATION INDICATED THAT NO PHYSICAL AND/OR DEVICE FUNCTIONAL CONDITION COULD BE FOUND THAT COULD BE CONSIDERED A CAUSAL FACTOR FOR THE REPORTED COMPLAINT OF "PAIN". NO FAILURE AND/OR FAULT CONDITION COULD BE FOUND AND CONFIRMED. THEREFORE, NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME. REVIEW OF COMPLAINT HISTORY IDENTIFIED (4) TOTAL COMPLAINTS FROM (MAY 5, 2020) TO (MAY 5, 2021) FOR PN (1067716, 1067717) AND EVENTS RELATED TO (PAIN). KEYWORD SEARCH CRITERIA: (COMPLAINT CODE: MEDICAL: PAIN). (B)(6) MEDICAL WILL CONTINUE TO MONITOR FOR TRENDS. DEVICE USAGE: THIS DEVICE IS USED FOR TREATMENT. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE SALES REP THAT THE PATIENT STATED THAT THE STIMULATOR HAS REVVED UP ALL OF MY NERVES. PATIENT STATED THAT IT MADE MY BACK, LEGS, AND FEET TINGLY...I COULDN¿T EVEN STAND ON MY FEET IT BOTHERED ME SO MUCH. PATIENT STARTED WEARING THE STIM ON FRIDAY EVENING AND SAID THAT HE DIDN¿T HAVE ISSUES THE INITIAL TWO DAYS, BUT THE PAIN BECAME UNBEARABLE ON SUNDAY. PATIENT STOPPED WEARING THE STIMULATOR ON SUNDAY AND SAID AFTER A COUPLE HOURS HIS PAIN/TINGLING WAS GONE AND IMPROVED. PATIENT HAS NOT RESTARTED WEARING THE STIM. PAIN IS BELOW THE SURFACE OF SKIN, PAIN LEVEL IS 8. ADDITIONAL INFORMATION: IT WAS LATER REPORTED THAT THE PATIENT CONTINUED TO WEAR THE UNIT FOR AN HOUR EACH DAY BUT WAS UNABLE TO TOLERATE HOW IT WAS AFFECTING HIS NERVES. THE PATIENT STATED THAT HE CONTINUED TO GET THE PIN PRICK TINGLING FEELING UP AND DOWN HIS LEGS. THE FEELING BECAME INTOLERABLE EVEN BEFORE THE HOUR WAS UP.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). DATE OF EVENT: (B)(6) 2021. MEDICAL PRODUCT: UNKNOWN. THERAPY DATE: UNKNOWN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP THAT THE PATIENT STATED THAT THE STIMULATOR HAS REVVED UP ALL OF MY NERVES. PATIENT STATED THAT IT MADE MY BACK, LEGS, AND FEET TINGLY...I COULDN¿T EVEN STAND ON MY FEET IT BOTHERED ME SO MUCH. PATIENT STARTED WEARING THE STIM ON FRIDAY EVENING AND SAID THAT HE DIDN¿T HAVE ISSUES THE INITIAL TWO DAYS, BUT THE PAIN BECAME UNBEARABLE ON SUNDAY. PATIENT STOPPED WEARING THE STIMULATOR ON SUNDAY AND SAID AFTER A COUPLE HOURS HIS PAIN/TINGLING WAS GONE AND IMPROVED. PATIENT HAS NOT RESTARTED WEARING THE STIM. PAIN IS BELOW THE SURFACE OF SKIN, PAIN LEVEL IS 8.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441744 SPINALPAK ASSEMBLY STIMULATOR, SPINALPAK, NONIVASIVE LOF EBI, LLC. N/A N/A 00812301020225

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose Required Intervention SEE H10 NARRATIVE