BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 4369155 · Received December 30, 2014

    Report

    Report Number
    3004209178-2014-24646
    Event Type
    Malfunction
    Date Received
    December 30, 2014
    Report Date
    December 9, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37744, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37651, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 3550-39, LOT# N287387, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 3550-P4, LOT# N320738, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 8591-38, LOT# D20365, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 37744, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS CHARGING MORE THAN EXPECTED. THE PATIENT WAS NOW CHARGING EVERY 3-4 DAYS SINCE THE PAST THREE MONTHS. THE PAST SUNDAY PRIOR TO THE REPORT, THE PATIENTS DEVICE WAS UP TO 100% FULL AND WHEN THE PATIENT CHECKED WITH THE PROGRAMMER, THE PROGRAMMER DISPLAYED ONLY 75% CHARGED. THE PATIENT DID SEE THE 3 TEAR DROPS AND JUST ON THE UPPER LEFT HAND CORNER, NO OTHER ICONS WERE SEEN ON THE TOP ROW. GROUP IMPEDANCE WAS AT 524 OHMS AT 5.563 MILLIAMPS. IMPEDANCES WERE WITHIN NORMAL LIMITS. THERE WERE ESTIMATES ON GROUP D AND H FOR RECHARGE INTERVALS. THE PATIENT USED THOSE THE MOST. FOR D THERE WAS 2 ANODES, 2 CATHODES; AMPLITUDE OF 3.3 VOLTS, 1000 MICROSECOND PULSE WIDTH, FREQUENCY OF 35HZ, IMPEDANCE OF 524 OHMS WHICH CAME TO BE 15.7 / 13.3 DAYS. FOR H THERE WAS 4 CATHODES, 1 ANODE, AMPLITUDE OF 1.8 VOLTS, 1000US, 55 MICROSECOND PULSE WIDTH, IMPEDANCE OF 407 OHMS WHICH CAME TO BE 15.3 / 13.03 DAYS. GROUP IMPEDANCES WERE TAKEN DURING THE CALL, AND HAD THE FOLLOWING IMPEDANCE READINGS: A 854, 858 OHMS , FOR 2 PROGRAMS; B 337 OHMS; C 648 OHMS; E 607 OHMS; F 500 OHMS; G 512 OHMS. IT WAS REPORTED THAT THERE WAS A FADING SENSATION. WHEN THE PATIENT WAS EXPERIENCING PARESTHESIA, STIMULATION WOULD GO TO SLEEP MODE AND THE PATIENT WOULDN¿T FEEL STIMULATION ANYMORE. THE PATIENT WOULD ONLY FEEL STIMULATION AGAIN IF HE INCREASED OR DECREASED STIMULATION USING THE PATIENT PROGRAMMER AND THEN STIMULATION WOULD COME BACK ON. THE PATIENT USED THE STIMULATION ON BUTTON DURING THOSE EVENTS SO THEY WOULD CONFIRM THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS INDEED ON. THE PATIENT NOTICED THIS ISSUE A LOT, IT OCCURRED ON A REGULAR BASIS, AND IT HAD BEEN OCCURRING FOR A YEAR. THE FIRST TIME THE PATIENT HAD SEEN A HEALTHCARE PROVIDER (HCP) FOR THIS SYSTEM WAS OVER A YEAR PRIOR. THE PATIENT NOTICED THIS ISSUE THE MOST WHEN HE WOKE UP THOUGH IT DIDN¿T SEEM TO BE RELATED TO HIS POSITION. THE ISSUE OCCURRED WITH ANY GROUP THAT HE WAS IN. IF THE PATIENT DIDN¿T DO ANYTHING WITH THE PROGRAMMER, STIMULATION WOULD NOT COME BACK ON. THIS ISSUE OCCURRED WHEN THE PATIENT DIDN¿T MOVE MUCH AT ALL, STAYED IN THE SAME POSITION. STIMULATION ON TIME WAS SHOWING 96% ON THE CLINICIAN PROGRAMMER. IT WAS UNKNOWN IF THE PATIENT HAD 50% PAIN RELIEF. IT WAS UNKNOWN IF THERE WAS AN ACTUAL ISSUE OR THE PATIENT WAS UNAWARE OF PARESTHESIA AT TIMES. THE PATIENT WAS ASKED TO CALL THE MANUFACTURER REPRESENTATIVE. THE PATIENT OUTCOME WAS UNKNOWN. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    860640 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