BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 7087505 · Received December 6, 2017

    Report

    Report Number
    3004209178-2017-24947
    Event Type
    Injury
    Date Received
    December 6, 2017
    Date of Event
    October 25, 2017
    Report Date
    December 6, 2017
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR SPINAL PAIN. IT WAS REPORTED THAT ONE OF THE PATIENT¿S INS¿S HAD THE DOCTOR ICON WITH ¿IER¿ POPPING UP. NO SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED. FOLLOW-UP WAS CONDUCTED. ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING THE PATIENT. IT WAS REPORTED THAT THE PATIENT CLARIFIED THE "IER" MESSAGE TO BE AN "END OF LIFE" MESSAGE ON THEIR RIGHT HIP UNIT ON (B)(6) 2017. THE PATIENT REPORTED THAT ON (B)(6) 2017, THE DEVICE WAS 9 YEARS OLD AND THEY WERE UNABLE TO RECHARGE ANYMORE. THE PATIENT STATED THAT THEY USED THEIR RIGHT HIP UNIT MORE THAN THEIR LEFT HIP UNIT. THEY REPORTED THE DEVICE WAS NO LONGER USABLE. WHEN ASKED ABOUT STEPS TAKEN TO RESOLVE THE DOCTOR ICON AND "IER," THE PATIENT STATED, "FAILED EMAILS/PHONE CALLS, USING EXTERNAL UNITS." THE PATIENT REPORTED THEY HAD SET UP A REPLACEMENT OF THE DEVICE WITH A HEALTHCARE PROFESSIONAL. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    867968 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention