BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM

    MDR report key: 6567862 · Received May 15, 2017

    Report

    Report Number
    0002242816-2017-00020
    Event Type
    Injury
    Date Received
    May 15, 2017
    Report Date
    May 15, 2017
    Manufacturer
    EBI, LLC.
    Product Code
    LOF
    PMA / PMN Number
    PP850022
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLETE PMA/(510K) #: P850022/S017. THE PRODUCT WAS DISCARDED BY THE PATIENT AND THEREFORE WILL NOT BE RETURNED FOR AN EVALUATION. BECAUSE THE LOT NUMBER IS UNKNOWN, THE DEVICE HISTORY RECORDS COULD NOT BE PULLED AND REVIEWED. THE PATIENT ADVISED SHE HAS SENSITIVE SKIN. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT, A FOLLOW-UP REPORT WILL BE SENT. THIS IS REPORT THREE OF THREE FOR THE SAME EVENT. REPORTS ONE AND TWO ARE REPORTED ON MFR #0002242816-2017-00018 AND 0002242816-2017-00019.

    Description of Event or Problem · 1

    THE PATIENT STATED THAT SHE PREVIOUSLY DEVELOPED A RASH WITH BLISTERS; SHE DID NOT REALIZE IT, BUT HER BACK WAS "BLACK AS THOUGH IT WAS BURNED." HER PRIMARY CARE PHYSICIAN PRESCRIBED BETAMETHASONE CREAM FOR HER SINCE IT WAS STRONGER THAN THE REGULAR OVER THE COUNTER CREAM. PATIENT STATED THAT THE MEDICATION WAS PRESCRIBED TO HER SPECIFICALLY FOR THE SYMPTOMS DEVELOPED FROM THE TREATMENT OF THE ELECTRODES. THE PATIENT CHANGED THE ELECTRODES DAILY AND WOULD USE THE CREAM WHENEVER HER ISSUES GOT BAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348598 SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM ELECTRODE COVER PATCHES LOF EBI, LLC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention