BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 4935225 · Received July 23, 2015

    Report

    Report Number
    3004209178-2015-13950
    Event Type
    Malfunction
    Date Received
    July 23, 2015
    Report Date
    July 2, 2015
    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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3888-45, LOT# V331906, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-45, LOT# V302548, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 3550-39, LOT# N171449, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 3888-45, LOT# V260571, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 3550-39, LOT# N137575, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IT HAD BEEN AWHILE SINCE THE LAST TIME THE PATIENT CHARGED THE IMPLANTABLE NEUROSTIMULATOR (INS) FULLY. THEY TURNED EVERYTHING OFF A COUPLE OF MONTHS PRIOR TO THE REPORT BECAUSE THEY WERE HAVING AN OPERATION WHICH WAS NOT RELATED TO THEIR DEVICE. THE PATIENT STATED THEY HADN'T USED IT AND NOW WANTED TO, BUT DIDN'T THINK THEY HAD TO KEEP THE DEVICE CHARGED IF THEY WEREN'T USING IT. HOWEVER, THE PATIENT WAS UNABLE TO RECHARGE AND THEY WERE GETTING THE REPOSITION ANTENNA SCREEN. THEY WERE NOT ABLE TO COMMUNICATE WITH THE RECHARGER OR THE PATIENT PROGRAMMER (PP). THE PP WAS USED AND THE PATIENT WAS SEEING THE POOR COMMUNICATION SCREEN. THE LAST TIME THE PATIENT FELT STIMULATION WAS IN (B)(6) 2015. IT WAS REVIEWED THAT IF THE TIME HAD BEEN GREATER THAN THREE MONTH TO CONSIDER THAT THE DEVICE MAY BE IN OVERDISCHARGE. 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.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT EXPERIENCED NO SYMPTOMS RELATED TO THE OVERDISCHARGE. THE PATIENT CALLED THE DOCTOR'S OFFICE TO RESOLVE THE OVERDISCHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481329 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