BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM

    MDR report key: 6810580 · Received August 22, 2017

    Report

    Report Number
    0002242816-2017-00039
    Event Type
    Injury
    Date Received
    August 22, 2017
    Report Date
    August 22, 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
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FULL #: P850022/S017. THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. THE PRODUCT WAS DISCARDED BY THE PATIENT AND WILL NOT BE RETURNED. BECAUSE THE LOT NUMBER IS UNKNOWN, THE DEVICE HISTORY RECORDS COULD NOT BE PULLED AND REVIEWED. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT. THIS IS REPORT ONE OF TWO FOR THE SAME EVENT. REPORT TWO OF TWO IS REPORTED ON MFR #0002242816-2017-00040.

    Description of Event or Problem · 1

    THE PATIENT STATES SHE RECEIVED THE SPINALPAK STIMULATOR ON (B)(6) 2017 FOR HER NECK. SHE CHANGED AND REPOSITIONED THE ELECTRODES AND COVER PATCHES EVERY TWO TO THREE DAYS. ON (B)(6) 2017, THE PATIENT EXPERIENCED A RASH WITH RED ITCHY PIMPLES THAT TURNED TO OPEN SORES UNDER THE 63B ELECTRODES AND COVER PATCHES. THE PATIENT WENT TO URGENT CARE WHERE SHE WAS PRESCRIBED A TRIPLE ANTIBIOTIC OINTMENT. THE PATIENT WILL USE THE LT4500 AND 72R ELECTRODES INSTEAD OF THE 63B ELECTRODES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591907 SPINALPAK NON-INVASIVE SPINE FUSION STIMULATOR SYSTEM SOFT-TOUCH ELECTRODES, 63B LOF EBI, LLC. N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention