BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 4409953 · Received January 12, 2015

    Report

    Report Number
    3004209178-2015-00558
    Event Type
    Malfunction
    Date Received
    January 12, 2015
    Report Date
    December 22, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 3778-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD; PRODUCT ID 3778-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS CHARGING MORE THAN EXPECTED. STARTING A FEW MONTHS PRIOR TO THIS REPORT, SHE WENT FROM CHARGING EVERY OTHER WEEK TO EVERY 2-3 DAYS. NO EVENT, TRAUMA, OR CHANGE IN PARAMETERS THAT MAY HAVE ACCOUNTED FOR THE CHANGE WERE REPORTED TO HAVE OCCURRED. THE PATIENT¿S DOCTOR HAD IDENTIFIED 2 POSSIBLE OPEN CIRCUITS WITH ELECTRODES 6 AND 13. ELECTRODE 0 WAS USED AS REFERENCE AND SAW ELECTRODES 6 AND 13 TO BE GREATER THAN 10,000 OHMS WITH THE REST OF THE IMPEDANCES RANGING FROM 938-1552 OHMS. ELECTRODE 1 WAS USED AS REFERENCE AND ELECTRODES 6 AND 13 WERE GREATER THAN 10,000 OHMS WITH THE REST BEING 918-1534 OHMS. ELECTRODES 6 AND 13 AS REFERENCE SHOWED ALL AS GREATER THAN 10,000 OHMS. AN ESTIMATE OF 9-10 DAYS WAS FOUND BUT NO RECHARGE STATISTICS WERE AVAILABLE AT THE TIME OF THIS REPORT. THE PATIENT WAS ADVISED TO GO HOME AND KEEP A DIARY OF CHARGING FOR LATER COMPARISON AGAINST THE CLINICIAN PROGRAMMER STATISTICS. IT WAS NOTED THAT THE FEW WEEKS PRIOR TO THIS REPORT HAD BEEN HARD FOR THE PATIENT TO CHARGE DUE TO PERSONAL ISSUES. GROUP D HAD BEEN USED WITH D1=450 MICROSECONDS, 40 HERTZ, 2.9 VOLTS, AND 336 OHMS AND D2=450 MICROSECONDS, 40 HERTZ, 3.4 VOLTS, AND 406 OHMS, 24 HOURS A DAY. FOLLOW-UP DETERMINED THAT THE PATIENT WAS HAVING GOOD STIMULATION DESPITE HAVING 2 ELECTRODES NOT FUNCTIONING PROPERLY. THE PATIENT HAD BEEN REPROGRAMMED NOT USING THOSE 2 ELECTRODES AND SHE WAS GETTING GREAT COVERAGE OF HER PAINFUL AREAS. THE PATIENT WAS MONITORING HER CHARGE INTERVALS AND WAS GOING TO CONTACT THE MANUFACTURER REPRESENTATIVE IF SHE SAW AN ABNORMAL CHARGE ISSUE. RECHARGING WAS REVIEWED WITH THE PATIENT AS WELL. NO FURTHER FOLLOW-UP WAS REQUIRED AS THE PATIENT WAS RECEIVING GOOD THERAPY AND WAS GOING TO MONITOR AND NOTIFY THE MANUFACTURER REPRESENTATIVE IF ABNORMAL CHARGING WAS SEEN.

    Description of Event or Problem · 1

    THE PATIENT¿S HEALTH CARE PROVIDER (HCP) REPORTED THE CAUSE OF THE IMPEDANCE ISSUE WAS UNKNOWN AND IT WAS UNKNOWN IF IT WAS DEVICE RELATED. THE PATIENT WAS ABLE TO BE REPROGRAMMED WITHOUT THE USE OF THE AFFECTED LEAD.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THERE WAS NO KNOWN CAUSE OF THE ELECTRODE IMPEDANCE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26038 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 00038 YR