BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPINALPAK ASSEMBLY

    MDR report key: 13255371 · Received January 13, 2022

    Report

    Report Number
    0002242816-2022-00002
    Event Type
    Death
    Date Received
    January 13, 2022
    Report Date
    April 26, 2023
    Manufacturer
    EBI, LLC.
    Product Code
    LOF
    UDI-DI
    00812301020201
    PMA / PMN Number
    P850022
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ZIMMER BIOMET (B)(4). MEDICAL PRODUCT: UNKNOWN. THERAPY DATE: UNKNOWN. THE CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE DEVICE WAS RETURNED TO ZIMVIE FOR INVESTIGATION. THE REPORTED EVENT WAS NOT VERIFIABLE AFTER THE INVESTIGATION ASSOCIATED WITH SKIN IRRITATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELATED TO THE REPORTED EVENT WERE FOUND. NO PHYSICAL AND/OR FUNCTIONAL CONDITION COULD BE FOUND AFTER THE DHR THAT COULD BE CONSIDERED A CAUSAL FACTOR FOR THE REPORTED COMPLAINT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY ZIMVIE WILL CONTINUE TO MONITOR FOR TRENDS. THE FOLLOWING SECTIONS HAVE BEEN UPDATED: B4: DATE OF THIS REPORT ADDED. D3: MANUFACTURER UPDATED. D4: LOT NUMBER ADDED. G1: CONTACT OFFICE UPDATED. G3: DATE RECEIVED BY MANUFACTURER ADDED. G6: TYPE OF REPORT. H2: FOLLOW UP TYPE. H3: DEVICE EVALUATED BY MANUFACTURER UPDATED TO YES. H4: DEVICE MANUFACTURER DATE ADDED. H6: COMPONENT CODES ADDED 451-ELECTRODES. H6: IMPACT CODE ADDED 4648-INSUFFICIENT INFORMATION. H6: DEVICE CODE UPDATED TO 2682 - PATIENT-DEVICE INCOMPATIBILITY. H6: INVESTIGATION CODE ADDED TO 3331 - ANALYSIS OF PRODUCTION RECORDS. H6: INVESTIGATION CODE ADDED TO 4119 ¿ INSUFFICIENT INFORMATION AVAILABLE. H6: INVESTIGATION FINDINGS CODE ADDED TO 3221: NO FINDINGS AVAILABLE. H10: ADDITIONAL NARRATIVES/DATA. THE FOLLOWING SECTIONS HAVE BEEN CORRECTED: H6: DEVICE CODE UPDATED TO 2993: ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A MINOR SKIN IRRITATION WITH THE 72R ELECTRODES. THE PATIENT ADVISED THAT HER SKIN WAS RED AND ITCHY, BUT THERE WERE NO BLISTERS OR WELTS. THE IRRITATION RESEMBLED PIMPLES. THERE WAS NO SWELLING. THE PATIENT ADVISED SHE CHANGED HER ELECTRODES DAILY AND ROTATED DAILY. SHE CLEANS THE AREA WITH SOAP AND WATER IN THE SHOWER. SHE DOES NORMALLY HAVE SENSITIVE SKIN AND IS SENSITIVE TO LATEX, ALTHOUGH ALLERGY TESTING WAS NEGATIVE TO LATEX ALLERGY. SOME OF HER ALLERGIES TO DRUGS INCLUDE: (B)(6). THE PATIENT REPORTS NO SEASONAL ALLERGIES BUT ALLERGY TESTING SHOWED AN ALLERGY TO ENGLISH PLANTAIN WEED. THE PATIENT DOES TAKE A BLOOD PRESSURE MEDICATION AS A BETA-BLOCKER. THE PATIENT SOUGHT THE ATTENTION OF HER SURGEON FOR HER IRRITATION, AND THEY SUGGESTED ROTATING THE ELECTRODES A LITTLE FARTHER APART TO GIVE HER MORE ROTATION LOCATIONS. THE DOCTOR ALSO SUGGESTED RUBBING (B)(6) ON THE SKIN, LETTING IT DRY, THEN PLACING ELECTRODES ON THE SKIN TO HELP PROTECT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A MINOR SKIN IRRITATION WITH THE 72R ELECTRODES. THE PATIENT ADVISED THAT HER SKIN WAS RED AND ITCHY, BUT THERE WERE NO BLISTERS OR WELTS. THE IRRITATION RESEMBLED PIMPLES. THERE WAS NO SWELLING. THE PATIENT ADVISED SHE CHANGED HER ELECTRODES DAILY AND ROTATED DAILY. SHE CLEANS THE AREA WITH SOAP AND WATER IN THE SHOWER. SHE DOES NORMALLY HAVE SENSITIVE SKIN AND IS SENSITIVE TO LATEX ¿ ALTHOUGH ALLERGY TESTING WAS NEGATIVE TO LATEX ALLERGY. SOME OF HER ALLERGIES TO DRUGS INCLUDE CYPRO, REMICADE, ARAVA, ACTIMROD, ORENCIA, HUMIRA, EGGS, ADHESIVE/BAND AIDES. THE PATIENT REPORTS NO SEASONAL ALLERGIES BUT ALLERGY TESTING SHOWED AN ALLERGY TO ENGLISH PLANTAIN WEED. THE PATIENT DOES TAKE A BLOOD PRESSURE MEDICATION AS A BETA-BLOCKER. THE PATIENT SOUGHT THE ATTENTION OF HER SURGEON FOR HER IRRITATION, AND THEY SUGGESTED ROTATING THE ELECTRODES A LITTLE FARTHER APART TO GIVE HER MORE ROTATION LOCATIONS. THE DOCTOR ALSO SUGGESTED RUBBING PEPTO BISMOL ON THE SKIN, LETTING IT DRY, THEN PLACING ELECTRODES ON THE SKIN TO HELP PROTECT. IT WAS REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1019463 SPINALPAK ASSEMBLY SPINAL PAK NON-INVASIVE STIMULATOR (SOFT TOUCH ELECTRODES, 72R) LOF EBI, LLC. N/A 118101 00812301020201

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention SEE H10 NARRATIVE.