BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3891621 · Received June 24, 2014

    Report

    Report Number
    3004209178-2014-11964
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Report Date
    June 3, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37712, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 3708160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION; PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3778-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION; PRODUCT ID 3550-29, LOT# N264299, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PATIENT FIRST HAD THEIR IMPLANTABLE NEUROSTIMULATOR (INS) THEY DID NOT NEED TO CHARGE THE INS EVERY DAY. THE REPORTER STATED THEY THEN HAD TO CHARGE IT EVERY DAY OTHERWISE IT WOULD GET DOWN TO 1/4. THE REPORTER FURTHER STATED THAT FOR THE LAST COUPLE WEEKS THEY HAD TO CHARGE TWICE A DAY OTHERWISE ¿IT WOULD SHUT ITSELF OFF.¿ IT WAS NOTED THE PATIENT WAS CHARGING MORE THAN EXPECTED. IT WAS FURTHER NOTED THE PATIENT SAW THEIR HEALTHCARE PROFESSIONAL (HCP) LAST WEEK AND THE HCP STATED TO KEEP AN EYE ON IT BECAUSE THE PATIENT¿S PARAMETERS WERE HIGH. IT WAS NOTED THE PATIENT WAS NOT ON AS HIGH OF SETTINGS NOW AS THEY WERE IN THE PAST. IT WAS FURTHER NOTED THE PATIENT¿S HCP THOUGHT THE INS WAS DYING BECAUSE IT WAS NOT HOLDING A CHARGE. IT WAS NOTED THE INS WAS AT C5-6 AND T7. IT WAS FURTHER NOTED THE PATIENT HAD A PAIN PUMP. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS STILL HAVING CONCERNS REGARDING THEIR DEVICE OR THERAPY, BUT THEY WERE WORKING WITH THEIR HCP OR A MANUFACTURING REPRESENTATIVE. IT WAS NOTED THE PATIENT¿S LAST APPOINTMENT WITH THEIR HCP WAS (B)(6) 2014 AND THE NEXT APPOINTMENT WAS (B)(6) 2014. THE REPORTER STATED THEY HAVE HAD A NUMBER OF INSS AND THEY HAVE A PAIN PUMP. THE REPORTER FURTHER STATED THEY HAVE HAD GREAT RESULTS WITH THESE FORMS OF PAIN CONTROL. IT WAS NOTED THE PATIENT HAD CONTACTED A MANUFACTURING REPRESENTATIVE AND THEY WERE WAITING TO BE CONTACTED BACK. IT WAS FURTHER NOTED THE PATIENT¿S HCP WANTED TO CONTINUE TO WATCH AND RECHECK THE INS. THE REPORTER STATED THEY WERE POSSIBLY HAVING RECHARGER BATTERY ISSUES AFTER 3.5 YEARS. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. REFER TO MANUFACTURER REPORT #3004209178-2014-11963.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368996 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 00054 YR