BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 4627884 · Received March 24, 2015

    Report

    Report Number
    3004209178-2015-05295
    Event Type
    Malfunction
    Date Received
    March 24, 2015
    Report Date
    February 28, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3708140, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 37752, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3777-45, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3550-29, LOT # N170538, IMPLANTED: (B)(6) 2009, PRODUCT TYPE ACCESSORY; PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED BY THE CONSUMER INDICATED THEY HAD NOT CHARGED THEIR STIMULATOR OR FELT STIMULATION SINCE 2011. THEY ADDITIONALLY NOTED THE DEVICE WAS NOT WORKING AND WAS DEAD. IT HAD NOT WORKED FOR OVER A YEAR; THE PATIENT ATTEMPTED TO INTERROGATE ABOUT A YEAR AGO WITH NO SUCCESS. THE PATIENT HAD AN MRI A WHILE AGO AND WAS TOLD THEIR STIMULATOR WAS DEPLETED. THE CONSUMER BELIEVED THIS WAS IN 2012 BUT THEY NOTED THEY HAD MEMORY AND COGNITION ISSUES. THE PATIENT HAD HAD TROUBLE GETTING RELIEF PRETTY MUCH SINCE THE YEAR IT WAS IMPLANTED. THEY ALSO INDICATED RECHARGING HAD BEEN A PROBLEM. THEY WOULD HAVE TO LAY A CERTAIN WAY ON IT AND IT WOULD TAKE 8 OR 16 HOURS TO GET IT CHARGED. THE PHYSICIAN SUGGESTED REPLACING THE DEVICE DUE TO END OF LIFE. NO INTERVENTIONS OR OUTCOME WAS NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A PROBLEM. IT HAD BEEN A WHILE SINCE THE PATIENT RECHARGED DUE TO A DEATH IN THE FAMILY FOLLOWED BY THE PATIENT HAVING TO ADDRESS MEDICAL ISSUES, WHICH WERE KIDNEY STONES. THE PATIENT WAS SEEN BY THE HEALTHCARE PROVIDER (HCP) OFFICE APPROXIMATELY 3-4 WEEKS PRIOR. THEY ATTEMPTED TO RECHARGE THE IMPLANTABLE NEUROSTIMULATOR (INS) BUT WERE UNSUCCESSFUL. IT FELT LIKE THE INS HAD SHIFTED IN THE POCKET. THE PATIENT INDICATED THAT SINCE IMPLANT, THEY HAD EXPERIENCED DIFFICULTY RECHARGING. THEY WERE HAVING ISSUES RECHARGING THEIR SPINAL CORD STIMULATOR (SCS) AND THE DEVICE SEEMED TO HAVE SHIFTED. THE PATIENT WAS INSTRUCTED TO START THE COUNTDOWNS OR THEY WERE GOING TO HAVE TO SIT IN THE WAITING ROOM AND CHARGE FOR MULTIPLE HOURS. THE PATIENT HAD BEEN DISCHARGED FOR AT LEAST 4 MONTHS OR LONGER. THE MANUFACTURER REPRESENTATIVE (REP) MADE THREE APPOINTMENTS WITH THE PATIENT IN THE MONTH PRIOR BUT THE PATIENT CANCELLED. THE BATTERY WAS OVERDISCHARGED. THE PATIENT DID NOT LIKE RECHARGING AND NOTED IT WAS INCONVENIENT. THE PATIENT HAD SCHEDULED TIMES TO GET IT CHECKED OUT BUT DUE TO A VARIETY OR REASONS HAD BEEN MISSING THEIR APPOINTMENTS. THE PATIENT WOULD SCHEDULE AN APPOINTMENT IN THE OFFICE IN THE NEXT FEW WEEKS FOLLOWING THE REPORT. IT WAS REPORTED A FEW YEARS LATER THAT THE PATIENT WAS HAVING AN MRI, FOR THE BRAIN, NOT RELATED TO THE DEVICE THERAPY. IT WAS NOTED THAT THE INS WAS NOT WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196012 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