BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3843830 · Received June 2, 2014

    Report

    Report Number
    3004209178-2014-09977
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 11, 2014
    Report Date
    May 13, 2014
    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
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3888-45, LOT# V570217, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3888-45, LOT# V593229, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS UNABLE TO ADJUST STIMULATION. IT WAS NOTED THE PATIENT SAW THE ¿CALL YOUR DOCTOR¿ ICON AND POWER ON RESET (POR) CONDITION. IT WAS REPORTED THE PATIENT SAW POR ON THE RECHARGER AND PROGRAMMER STARTING A COUPLE OF DAYS PRIOR TO CALL. IT WAS REPORTED THE PATIENT WAS ABLE TO CLEAR THE POR ON THE PROGRAMMER WITH THE NAVIGATOR BUTTON.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT AN IMPLANTABLE NEUROSTIMULATOR (INS) OVERDISCHARGE WAS SUSPECTED. THE PATIENT REPORTED THEIR BATTERY HAD ¿GONE DEAD¿ AND SHE WANTED TO KNOW WHAT TO DO. THERE WAS A COMMUNICATION PROBLEM AND THE PATIENT ONLY OBSERVED THE REPOSITION ANTENNA SCREEN. THE PATIENT ALSO OBSERVED THE POOR COMMUNICATION SCREEN ON THE PATIENT PROGRAMMER. THE LAST SUCCESSFUL RECHARGE WAS FOUR MONTHS PRIOR (B)(6) 2014. THE PATIENT HAD BEEN IN PAIN LATELY. THE PATIENT ALWAYS HAD PAIN BUT IN (B)(6) THE PAIN INCREASED BECAUSE SHE HAD NOT BEEN USING THE STIMULATOR. THE PATIENT STATED IT WAS IN HER BACK. THE PATIENT STATED SHE THOUGHT SHE CALLED ONCE BEFORE ABOUT THIS ISSUE BUT NEVER DID ANYTHING ABOUT IT. THE ISSUE BEGAN A ¿COUPLE OF MONTHS¿ PRIOR TO (B)(6) 2014. THE PATIENT WAS ¿SICK FOR A WHILE¿ AND WAS NOT ABLE TO GET IT TAKEN CARE OF. THE PATIENT WAS REDIRECTED TO THE HEALTHCARE PROFESSIONAL (HCP). NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321323 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 00062 YR