BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOFT-TOUCH ELECTRODES, 72R

    MDR report key: 7128996 · Received December 19, 2017

    Report

    Report Number
    0002242816-2017-00054
    Event Type
    Injury
    Date Received
    December 19, 2017
    Report Date
    May 2, 2019
    Manufacturer
    EBI, LLC.
    Product Code
    LOF
    PMA / PMN Number
    PP850022
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS NOT CONFIRMED DUE TO PRODUCT NOT BEING RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (HR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH COULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT EXPERIENCED A RASH/ WELTS THREE TO FOUR DAYS AFTER HE BEGAN TREATING WITH AN ELECTRODE (LT4500) AND COVER PATCHES FOR THE SPINALPAK. THE PATIENT ADVISED HE WORE THIS ELECTRODE AND COVER PATCHES CONTINUOUSLY DURING THIS TIME. THE PATIENT WAS ADVISED TO TRY ANOTHER TYPE OF ELECTRODE (72R) WITHOUT THE COVER PATCHES. THE PATIENT ADVISED THAT THE AREA FLARED UP AGAIN AFTER FOUR HOURS WITHOUT THE COVER PATCHES. THE PATIENT WOULD RELOCATE THE ELECTRODES AFTER THREE TO FOUR DAYS OF USE. SINCE HE HAS A SMALL AREA TO WORK WITH, THE AREA COVERAGE WOULD OVERLAP. HE CONTACTED HIS DOCTOR WHO STATED THE PATIENT WAS PROBABLY ALLERGIC. HIS DOCTOR PRESCRIBED ANTIBIOTICS AND A STEROID CREAM. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCT: EBI, LLC SPINALPAK(R) ASSEMBLY, CATALOG #: 1067716; EBI, LLC ELECTRODES, LT-4500 CATALOG #: 106130-12; EBI, LLC ELECTRODE COVER PATCHES CATALOG #: 106130-17. THERAPY DATE: UNKNOWN. PMA/510(K) #: P850022/S017. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THEY HAVE BEEN DISCARDED. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO THE PART NOT BEING RECEIVED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0002242816-2017-00053 AND 0002242816-2017-00055.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A RASH/ WELTS THREE TO FOUR DAYS AFTER HE BEGAN TREATING WITH AN ELECTRODE (LT4500) AND COVER PATCHES FOR THE SPINALPAK. THE PATIENT ADVISED HE WORE THIS ELECTRODE AND COVER PATCHES CONTINUOUSLY DURING THIS TIME. THE PATIENT WAS ADVISED TO TRY ANOTHER TYPE OF ELECTRODE (72R) WITHOUT THE COVER PATCHES. THE PATIENT ADVISED THAT THE AREA FLARED UP AGAIN AFTER FOUR HOURS WITHOUT THE COVER PATCHES. THE PATIENT WOULD RELOCATE THE ELECTRODES AFTER THREE TO FOUR DAYS OF USE. SINCE HE HAS A SMALL AREA TO WORK WITH, THE AREA COVERAGE WOULD OVERLAP. HE CONTACTED HIS DOCTOR WHO STATED THE PATIENT WAS PROBABLY ALLERGIC. HIS DOCTOR PRESCRIBED ANTIBIOTICS AND A STEROID CREAM. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907851 SOFT-TOUCH ELECTRODES, 72R STIMULATOR, BONE GROWTH, NON-INVASIVE LOF EBI, LLC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention