BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 4162294 · Received October 10, 2014

    Report

    Report Number
    3004209178-2014-19406
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Report Date
    September 22, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3708120, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 3708120, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 37752, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 39565-30, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 8840, SERIAL # UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN; PRODUCT ID 37743, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD NO STIMULATION SENSATION TWO OR THREE TIMES A WEEK. THE PATIENT FELT NO STIMULATION WHEN THEY WERE EITHER WALKING OR DRIVING THEIR TRUCK, BUT NEVER AT NIGHT. A MONTH PRIOR TO THIS REPORT THE PATIENT WAS WALKING AND THEIR FELT THEIR STIMULATION TURNED OFF. AROUND THE TIME THE PATIENT FELT NO STIMULATION THEY HAD FALLEN AND THE PATIENT DID FALL OFTEN. THE PATIENT WAS GETTING OUT OF THEIR TRUCK THEY FELL FACE DOWN AND LANDED ON THEIR SIDE BY THE INS. THE PATIENT PROGRAMMER WOULD NOT RESPOND AND THE RECHARGER HAD A CONNECTION ISSUE, BUT AFTER A WHILE THE PATIENT WAS ABLE TO CONNECT TO THE IMPLANTABLE NEUROSTIMULATOR (INS) WITH THE RECHARGER. THE PATIENT HAD CHARGED THE INS TO 75 PERCENT THE NIGHT BEFORE. A MANUFACTURING REPRESENTATIVE INTERROGATED THE INS AND THE SYSTEM CHECKED OUT FINE AND IMPEDANCES WERE NORMAL. IMPEDANCES WERE TESTED AT 0.7V WITH THE PATIENT WALKING AROUND THE ROOM. REFERENCE ZERO AND ELECTRODES 1, 2, 4, 10, 11, AND 14 HAD IMPEDANCES OF GREATER THAN 10,000 OHMS. REFERENCE 11 AND ELECTRODES 0, 1, 2, 3, 4, 5, 10, 12, 14, AND 15 HAD IMPEDANCES OF GREATER THAN 10,000 OHMS. IMPEDANCES WERE RETESTED AT 1.5 V WITH THE PATIENT WALKING AND TWISTING. HIGH AND LOW IMPEDANCES WERE MEASURED WITH REFERENCE ZERO AND 11. THE PATIENT HAD TWO PROGRAMS. PROGRAM A1 WAS SET TO 0-, 1+, 5-, 6+ AT 2.1V, 420 PULSE WIDTH, AND 40 HZ. PROGRAM A2 WAS SET TO 11-, 12+, 13- AT 1V, 420 PULSE WIDTH, AND 40 HZ. THERAPY IMPEDANCE FOR PROGRAM A1 AND A2 MEASURED WITH WALKING AND TWISTING WAS 604 OHMS AND 781 OHMS. FOLLOW UP WITH A MANUFACTURING REPRESENTATIVE INDICATED THERE WAS AN INTERMITTENT HIGH IMPEDANCE ISSUE. NO X-RAYS WERE TAKEN. REPROGRAMMING WAS DONE ON THE DAY OF THIS REPORT AND THE MANUFACTURING REPRESENTATIVE WAS ABLE TO PROGRAM AROUND THE HIGH IMPEDANCE CONTACTS TO PROVIDE THE PATIENT WITH THE COVERAGE THEY NEEDED. NO INTERVENTION WAS PLANNED AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640149 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 00057 YR