BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3922738 · Received July 9, 2014

    Report

    Report Number
    3004209178-2014-12723
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Report Date
    June 17, 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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: 2011 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: 2011 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 37752, SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID 37743, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A SUSPECTED OVERDISCHARGE. IT WAS NOTED THAT THE PATIENT¿S INS HAD BEEN OVERDISCHARGED TWICE BEFORE. IT WAS STATED THAT IT WAS PLANNED TO EXPLANT AND REPLACE THE DEVICE. IT WAS STATED THAT THERE WAS TROUBLE GETTING ¿THE 60 MINUTE TIMER UP,¿ BUT AFTER ASSISTANCE WAS ABLE TO DO SO. IT WAS STATED THAT THE CLINICIAN PROGRAMMER (CP) WOULDN¿T CONNECT WITH THE IMPLANTABLE NEUROSTIMULATOR (INS). ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE OVERDISCHARGE WAS THE THIRD OVERDISCHARGE. IT WAS STATED THAT THEY WERE TRYING TO CHARGE TO ¼ FULL IN ORDER TO CHECK THE LEADS AND IMPEDANCES. IT WAS NOTED THAT THE AVERAGE COUPLING STRENGTH WAS 5 BARS. IT WAS NOTED THAT THE BATTERY WAS AT 3.425VOLTS. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS A CONFIRMED OVERDISCHARGE. IT WAS STATED THAT A PHYSICIAN MODE RECHARGE (PMR) WAS ABLE TO SUCCESSFULLY RESET THE INS. IT WAS NOTED THAT IMPEDANCE TESTING HAD BEEN DONE. IT WAS FURTHER NOTED THAT THERE HAD NOT BEEN ANY SYMPTOMS RELATED TO THE EVENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT IT WAS NOT THE THIRD OVERDISCHARGE AS THE PATIENT WAS ABLE TO CHARGE FULLY AND RESUME THE STIMULATION. IT WAS NOTED THAT THE OVERDISCHARGE WAS DUE TO THE PATIENT NOT HAVING BEEN CHARGING THE INS. IT WAS STATED THAT THE PATIENT HAD NOT BEEN RECEIVING ANY STIMULATION DURING THE OVERDISCHARGE PERIOD. IT WAS STATED THAT THERE WERE 3 CONTACTS ON THE LEFT LEAD THAT HAD IMPEDANCES OF ¿>10,000OHMS.¿ IT WAS STATED THAT THE INS EXPLANT AND REVISION WAS NO LONGER PLANNED. IT WAS STATED THAT THE PATIENT WAS RECEIVING STIMULATION IN THE AREAS OF CHRONIC PAIN AND WAS RECEIVING EFFECTIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401222 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 00050 YR