BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 4853502 · Received June 18, 2015

    Report

    Report Number
    3004209178-2015-11825
    Event Type
    Malfunction
    Date Received
    June 18, 2015
    Report Date
    May 28, 2015
    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

    PRODUCT ID 3708160, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE RECHARGER PRODUCT ID 3708160, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 39565-30, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 37743, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE PROGRAMMER, PATIENT. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS STIMULATION IN THE WRONG LOCATION. THE PATIENT NOTICED THEIR STIMULATION WAS IN A DIFFERENT LOCATION AFTER THEY GOT OUT OF A POOL. THERE WERE IMPEDANCE READINGS OF GREATER THAN 10,000 OHMS ON CONTACT 6 AND 13. THE MANUFACTURER REPRESENTATIVE (REP) INQUIRED WHY THE OUT OF RANGE BOX WAS SHOWING GREATER THAN 10,000 OHMS BUT DOWN BELOW IT WAS SHOWING LESS THAN 10,000 OHMS. LATER, IT WAS REPORTED THAT THE LOWEST IMPEDANCE VALUE WAS 513 AND THE HIGHEST WAS AT 9,704 BUT I T WAS UNCLEAR IF THE REP WAS CHECKING ALL REFERENCES AT THAT POINT. IF THEY INCREASED THE IMPEDANCE TO 1.5 VOLTS THEY BECAME WITHIN NORMAL RANGE. THEY WERE STILL A LITTLE BIT HIGHER BUT WITHIN RANGE. THE PATIENT WAS PROGRAMMED ON ELECTRODE 13 AT THE TIME OF THE REPORT. THERE WAS A 50 PERCENT OR GREATER SYMPTOM REDUCTION. THE CAUSE OF THE EVENT WAS NOT DETERMINED AND NOT DETERMINED IF IT WAS DEVICE RELATED. REPROGRAMMING WAS NEEDED AND THEY REPROGRAMMED TO AVOID THE CONTACT THAT WAS ¿OOR¿ (OUT OF RANGE). THEY DID IMAGING DONE BY THE OFFICE THAT DETERMINED THE LEAD HAD NOT MOVED. THIS WAS ALL DONE THE DAY OF THE REPORT. IT WAS UNKNOWN HOW THE PATIENT WAS DOING AND IF THEY WERE RECEIVING EFFECTIVE THERAPY. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396786 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