BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINALPAK ASSEMBLY

    MDR report key: 10831616 · Received November 12, 2020

    Report

    Report Number
    0002242816-2020-00120
    Event Type
    Injury
    Date Received
    November 12, 2020
    Report Date
    June 19, 2024
    Manufacturer
    EBI, LLC.
    Product Code
    LOF
    UDI-DI
    00812301020218
    PMA / PMN Number
    P850022
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTIONS IN - B4: DATE OF THE REPORT, B5: EVENT DESCRIPTION, D3: MANUFACTURER, D4: UDI, D8A, E3, G1: CONTACT OFFICE, G6: TYPE OF REPORT. ADDITIONAL INFORMATION IN- D9, G3, H4: DEVICE MANUFACTURE DATE, H2, H3, H6: DEVICE CODE, IMPACT CODE, METHOD, RESULTS, AND H10: ADDITIONAL NARRATIVE, H11. 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 REVIEW HAS INDICATED NO REPORTED NON-CONFORMANCES OR DEVIATIONS. THE FAILURE WAS NOT CONFIRMED FOR THE REPORTED CONDITION OF THE "EXPERIENCED PAIN". THE UNIT WAS TESTED AND THE UNIT STOPPED BEEPING WHEN THE DUMMY LOAD WAS ENTERED. THE SPINALPAK STIMULATOR COMPLIANCE DATA WAS DOWNLOADED ON (B)(6) 2024. THE COMPLIANCE DATA INDICATES THE UNIT TREATED FOR 0 DAYS 23 HOURS AND 35 MINUTES. THE CLOCK LIFETIME OF THE SPINALPAK STIMULATOR WAS 1348 DAYS. THE CONTROLLER AUTOMATICALLY ENTERS ¿END OF LIFETIME MODE¿ AFTER 270 DAYS AS PER DSD-00173 REVISION A AND DSD-00116-SRS ((B)(6)) 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 115.6 USEC (SPECIFICATION - OUTPUT PERIOD FROM 15.2USEC ¿ 18.5USEC) ¿¿PASS¿. THE MEASURED OUTPUT AMPLITUDE WAS 6.23 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 (B)(6) 2025; AND TF1930 S/N (B)(6) WITH A CALIBRATION DUE DATE OF(B)(6) 2025. TEST/INSPECTIONS WERE COMPLETED BY THE QUALITY DEPARTMENT ON (B)(6) 2024. REVIEW OF COMPLAINT HISTORY IDENTIFIED (9) TOTAL COMPLAINTS FROM ((B)(6) 2019) TO ((B)(6) 2020) FOR PN (1067716, 1067717) AND EVENTS RELATED TO (PAIN). KEYWORD SEARCH CRITERIA: (COMPLAINT CODE: MEDICAL: PAIN) THE SEARCH COULD NOT BE SPECIFIED FURTHER. 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. (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 THAT THE PATIENT WAS EXPERIENCING TREMENDOUS PAIN WHILE USING THE SPINAL PAK STIMULATOR. THE PAIN STARTED THE NEXT DAY INTO TREATING WITH THE SPINAL PAK. THE PATIENT DESCRIBED THE PAIN AS HORRIBLE BACK SPASMS IN THE LUMBAR AREA. THE PAIN WAS BELOW THE SKIN. THE PATIENT RATED THE PAIN AS A 10 ON A SCALE OF 1 TO 10, WITH 10 BEING THE HIGHEST. THE PATIENT CONTACTED THE DOCTOR'S OFFICE REGARDING THE HORRIBLE BACK SPASMS BUT SHE DID NOT MENTION THE STIMULATOR. THE PATIENT WAS PRESCRIBED A STRONGER MUSCLE RELAXER. THE DAILY ACTIVITIES WERE NOT INCREASED. THE PAIN SUBSIDED WHEN SHE STOPPED USING THE STIMULATOR. THE PATIENT SAYS SHE IS DOING MUCH BETTER SINCE SHE STOPPED USING THE STIMULATOR. THE PATIENT ONLY HAS PAIN WHEN SHE BENDS A CERTAIN WAY. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT: THE EVENT OCCURRED SOMETIME IN (B)(6) 2020. CONCOMITANT MEDICAL PRODUCT: PEDICLE SCREW. 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 THAT THE PATIENT WAS EXPERIENCING TREMENDOUS PAIN WHILE USING THE SPINAL PAK STIMULATOR. THE PAIN STARTED THE NEXT DAY INTO TREATING WITH THE SPINAL PAK. THE PATIENT DESCRIBED THE PAIN AS HORRIBLE BACK SPASMS IN THE LUMBAR AREA. THE PAIN WAS BELOW THE SKIN. THE PATIENT RATED THE PAIN AS A 10 ON A SCALE OF 1 TO 10, WITH 10 BEING THE HIGHEST. THE PATIENT CONTACTED THE DOCTOR'S OFFICE REGARDING THE HORRIBLE BACK SPASMS BUT SHE DID NOT MENTION THE STIMULATOR. THE PATIENT WAS PRESCRIBED A STRONGER MUSCLE RELAXER. THE DAILY ACTIVITIES WERE NOT INCREASED. THE PAIN SUBSIDED WHEN SHE STOPPED USING THE STIMULATOR. THE PATIENT SAYS SHE IS DOING MUCH BETTER SINCE SHE STOPPED USING THE STIMULATOR. THE PATIENT ONLY HAS PAIN WHEN SHE BENDS A CERTAIN WAY. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1297232 SPINALPAK ASSEMBLY STIMULATOR, SPINE FUSION STIMULATOR, NON-INVASIVE LOF EBI, LLC. N/A N/A 00812301020218

    Patients

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