BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 4093549 · Received September 16, 2014

    Report

    Report Number
    3004209178-2014-17126
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Report Date
    August 19, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION; PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION; PRODUCT ID 39565-30, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    A FIRST OVERDISCHARGE WAS CONFIRMED. THE PATIENT EXPERIENCED LOSS OF STIMULATION IN THE BILATERAL LOWER EXTREMITIES AND INCREASED PAIN. THE PATIENT HAD NOT HAD STIMULATION FOR ABOUT A YEAR. A PHYSICIAN MODE RECHARGE (PMR) WAS PERFORMED WHICH SUCCESSFULLY RESET THE DEVICE. THE DEVICE WAS REPROGRAMMED AND IMPEDANCE TESTING WAS PERFORMED. THE REPROGRAMMING PROVIDED BETTER COVERAGE OF BILATERAL LEGS AND LOW BACK. AT THE TIME OF THE REPORT THE PATIENT WAS ALIVE WITH NO INJURY AND RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S IMPLANT HAD NOT WORKED FOR ABOUT A YEAR. ABOUT A YEAR PRIOR TO THE REPORT, THE PATIENT WAS RECHARGING THE IMPLANTABLE NEUROSTIMULATOR (INS) AND IT SHOWED FULLY CHARGED, BUT WHEN HE TRIED TO TURN THE STIMULATION ON WITH THE PATIENT PROGRAMMER, HE WASN¿T ABLE TO. THE PATIENT TRIED A FEW TIMES TO USE THE PATIENT PROGRAMMER TO TURN THE STIMULATION ON FOR SEVERAL DAYS. THE PATIENT HAD NOT RECHARGED THE INS IN ABOUT A YEAR. THE PATIENT WAS STILL HAVING CONCERNS REGARDING THE DEVICE OR THERAPY, BUT HE WAS WORKING WITH THE PHYSICIAN OR MANUFACTURING REPRESENTATIVE. THE PATIENT HAD AN APPOINTMENT ON (B)(6) 2014. INTERVENTIONS AND PATIENT OUTCOME WERE NOT REPORTED. FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573194 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 00062 YR