BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 6535072 · Received May 1, 2017

    Report

    Report Number
    3004209178-2017-09406
    Event Type
    Malfunction
    Date Received
    May 1, 2017
    Date of Event
    April 27, 2017
    Report Date
    May 31, 2017
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    UDI-DI
    00613994842343
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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

    ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER VIA A MANUFACTURER'S REPRESENTATIVE (REP). IT WAS REPORTED THAT THE REP MET WITH THE PATIENT AND INTERROGATED THE INS AND GOT A POR MESSAGE WITH CODE 0X400. TECHNICAL SERVICES REVIEWED THE MEANING OF THE CODE AND CALLER STATED THAT THE PATIENT DIDN'T RECALL SEEING A POR ON THE PROGRAMMER AT ALL. THEY JUST STATED THAT THEY SAW A POOR COMMUNICATION SCREEN. THE CALLER CHECKED THE IMPEDANCES AND NONE WERE OVER 10,00 BUT SOME WERE BETWEEN 2000-600 OHMS. THE CALLER STATED THAT THEY COULDN'T USE THE ORIGINAL SETTINGS WHICH HAD A CATHODE/ANODE ON BOTH LEADS AND WAS MAXED OUT. NOW WITH AN ANODE/CATHODE/CATHODE/ANODE AND NOW HAS COVERAGE IN BOTH LEGS. THE CALLER STATED THAT THIS IS THE FIRST TIME THAT HIGH IMPEDANCES WERE NOTICED. THE PATIENT GOT A THE DEVICE IN 2013 AND IT WAS QUESTIONED IF THERE WAS AN ISSUE WITH THE LEADS/ HIGH IMPEDANCE AT THAT TIME. THE PATIENT CAN CONTINUE TO USE THE SYSTEM NORMALLY SINCE THE POR WAS CLEARED AND THEY ARE GETTING COVERAGE. IF THE PATIENT SEES A POR AGAIN OR LOSES COVERAGE THEY SHOULD HAVE THE INS CHECKED AGAIN. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR NON-MALIGNANT PAIN. THE PATIENT REPORTED THAT THERE WAS NO STIMULATION. THE PATIENT REPORTED THAT SHE TURNED HER THERAPY OFF AND WHEN SHE WENT TO TURN IT BACK ON, IT GAVE OUT TWO LITTLE ¿SHOCKS/ZAPS/VOLTS¿ AND THEN SHE COULD NO LONGER FEEL STIMULATION. THE PATIENT REPORTED THAT HER STIMULATION WAS USUALLY SET TO 9 OR 9.5V BUT SHE HAD INCREASED TO 10.5 AND STILL COULDN¿T FEEL STIMULATION. THE PATIENT REPORTED THAT SHE JUST CHARGED THE INS ON THE DAY PRIOR TO THE REPORT. THERE WERE NO FALLS OR TRAUMAS THAT COULD BE RELATED TO THIS ISSUE. DURING THE CALL, THE PATIENT CHANGED TO GROUP Z AND INCREASED TO 10.5 AND REPORTED THAT SHE STILL COULD NOT FEEL ANY STIMULATION. NO FURTHER COMPLICATIONS ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314908 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712 00613994842343

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR