BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3913204 · Received July 3, 2014

    Report

    Report Number
    3004209178-2014-12514
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Report Date
    June 10, 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
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3550-29, LOT # N300846, IMPLANTED: (B)(6) 2012, PRODUCT TYPE ACCESSORY; PRODUCT ID 355531, LOT # N303385, IMPLANTED: (B)(6) 2012, PRODUCT TYPE SCREENING DEVICE; PRODUCT ID 3778-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL # (B)(4), PRODUCT TYPE RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN IMPLANTABLE NEUROSTIMULATOR (INS) OVERDISCHARGE WAS SUSPECTED. IT WAS NOTED THAT PATIENT COMPLIANCE WAS THE PRIMARY REASON FOR THE OVERDISCHARGE. IT WAS FURTHER NOTED THAT A COMMUNICATION PROBLEM WAS REPORTED. THE REPORTER STATED THE LAST TIME ANY STIMULATION WAS FELT WAS CLOSE TO A YEAR AGO. THE REPORTER FURTHER STATED THAT ONE DAY THEY TRIED TO CHARGE THE INS AND THEY COULD NOT CHARGE IT. IT WAS NOTED THE PATIENT DID NOT REMEMBER WHAT SCREEN THEY WERE GIVEN. IT WAS FURTHER NOTED THE LAST SUCCESSFUL RECHARGING SESSION WAS CLOSE TO A YEAR AGO. THE REPORTER STATED THEY SAW A POOR COMMUNICATION SCREEN WHEN TRYING TO USE THE PATIENT PROGRAMMER. THE REPORTER FURTHER STATED THAT RIGHT BEFORE THE INS STOPPED WORKING ABOUT A YEAR AGO THE INS WAS GETTING REAL HOW WHEN THEY WOULD CHARGE. IT WAS NOTED THE PATIENT ENDED UP WITH A BLISTER OVER THE INS. IT WAS FURTHER NOTED THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. THE REPORTER STATED THEY HAD BEEN GOING TO A CHIROPRACTOR AND HAVING ACUPUNCTURE A LOT FOR THEIR BACK. THE REPORTER FURTHER STATED THEIR BACK WAS HURTING AT THE TIME WHEN THE INS STOPPED WORKING. IT WAS NOTED THE PATIENT FELL 4-5 DAYS AGO AND THEY WENT TO THE EMERGENCY ROOM, BUT THEY DID NOT LOOK AT THE INS. IT WAS FURTHER NOTED THE PATIENT DID NOT HURT THEIR BACK, BUT THEY HURT THEIR ANKLE. THE REPORTER STATED THEY WERE LUCKY AND THEY HIT THEIR HIP AND HEAD. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS REPORTING A SIGNIFICANT TEMPERATURE CHANGE AND GETTING HOT DURING THE RECHARGER PROCESS. IT WAS NOTED THE PATIENT¿S INS WAS CURRENTLY OVERDISCHARGED. IT WAS FURTHER NOTED THAT JUST PRIOR TO BEING OVERDISCHARGED, THE PATIENT GOT A SORE AT THE INS SITE FROM RECHARGING. THE REPORTER STATED THEY WERE GOING TO BRING A NEW RECHARGER WHEN THEY MET WITH THE PATIENT TOMORROW FOR TROUBLESHOOTING. THE REPORTER FURTHER STATED THE PATIENT BELIEVED THAT IT HAD BEEN 7-8 MONTHS SINCE THE LAST RECHARGE. IT WAS NOTED THE PATIENT INDICATED THAT RECHARGING HEAD GOT SO HOT IT PUT A BLISTER ON THEIR SKIN AND THEY COULD NOT CHARGE THE INS ANYMORE. IT WAS FURTHER NOTED THAT THE PATIENT STOPPED RECHARGER BECAUSE IT GOT SO HOT WHEN RECHARGING. THE REPORTER STATED THEY EXPERIENCED THE BLISTER 6-7 MONTHS AGO. THE REPORTER FURTHER STATED THE SITE LOOKED LIKE A BRUISE RIGHT NOW. IT WAS NOTED THE PATIENT HAD NOT BEEN HIT AND THEY HAD NO TRAUMA. IT WAS FURTHER NOTED THE PATIENT DESCRIBED THE CURRENT INS SITE AS A BRUISE AND RED COLORED. THE REPORTER STATED IT STARTED GETTING HOT 1.5 YEARS AGO. THE REPORTER FURTHER STATED THEY SAW THEIR HEALTHCARE PROFESSIONAL (HCP) 1.5 MONTHS AGO AND THE BRUISE WAS NOT ADDRESSED BY THE HCP AT THAT TIME. IT WAS NOTED THE MANUFACTURING REPRESENTATIVE WAS GOING TO MEET WITH THE PATIENT TOMORROW FOR A PHYSICIAN MODE RECHARGE (PMR). ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS IN OVERDISCHARGE. THE REPORTER STATED THAT THIS HAD BECOME A PROBLEM SEVER AL MONTHS AGO. ADDITIONAL INFORMATION RECEIVED REPORTED THAT A POWER ON RESET (POR) WAS ENCOUNTERED ON THE DAY OF THIS REPORT. IT WAS NOTED THE PATIENT HAD THE NORMAL CHARGING SCREEN. THE REPORTER STATED THE OVERDISCHARGE WAS RESOLVED, BUT THE POR WAS UNRESOLVED AT THIS TIME. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389968 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