BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 7085311 · Received December 5, 2017

    Report

    Report Number
    3004209178-2017-24910
    Event Type
    Malfunction
    Date Received
    December 5, 2017
    Report Date
    February 6, 2018
    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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    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 PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR CHRONIC LOW BACK PAIN. THE PATIENT REPORTED THAT AN INFORMATION POWER ON RESET (POR) CODE WAS SEEN. THE PATIENT REPORTED THAT HE WAS PLANNING TO GO SEE A MANUFACTURER¿S REPRESENTATIVE (REP) ON (B)(6) 2017 SINCE HE WAS SEEING ¿POH¿ ON THE PATIENT PROGRAMMER SCREEN. THE PATIENT WAS ASSISTED IN SUCCESSFULLY CLEARING THE POR. THE PATIENT REPORTED THAT HE WAS NOW ABLE TO TURN STIMULATION BACK ON AGAIN. THE PATIENT ALSO REPORTED THAT HE HAD NECK PAIN. NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. THE PATIENT REPORTED THAT THE CIRCUMSTANCES THAT LEAD TO THE POWER ON RESET (POR) AND BACK PAIN WAS THAT IT QUIT WORKING. THE PATIENT REPORTED THAT HE CALLED AND HIS PROBLEM WAS FIXED. THE ISSUE WAS RESOLVED. NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. THE PATIENT REPORTED THAT HE GOT HIS UNIT THREW THE VA AND HAD AN APPOINTMENT AND DECIDED NOT TO WAIT AND CALLED THE MANUFACTURER. THE PATIENT REPORTED THAT HE CALLED THE MANUFACTURER AND GOT A HOLD OF A NICE YOUNG LADY AND SHE FIXED THE PROBLEM AND WAS VERY NICE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863452 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