BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 5288916 · Received December 11, 2015

    Report

    Report Number
    3004209178-2015-24888
    Event Type
    Malfunction
    Date Received
    December 11, 2015
    Report Date
    November 16, 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT AND A MANUFACTURER REPRESENTATIVE REPORTED THAT THE IMPEDANCES WERE CHECKED AT 0.7V AND AT 1.50V. BOTH CONTACTS 8 AND 9 WERE SHOWING <(><<)>50 OHMS. THE REST OF THE CONTACTS WERE SHOWING WITHIN NORMAL RANGE OF 500 TO 900 OHMS. THEY HAD FLIPPED THROUGH ALL REFERENCE ELECTRODES. WHEN THE IMPEDANCES WERE CHECKED AT 1.5V THE PATIENT FELT A ZING UP THEIR THORACIC AREA. THE PATIENT WAS ON GROUP A AND HAD 2 PROGRAMS. PROGRAM 1 WAS NOT IN USE AND WAS AT 0V. THE THERAPY IMPEDANCES WERE A1 - NOT APPLICABLE AND A2- 262 OHMS AND 10.6 MILLIAMPS. THERE WERE NO FALLS OR TRAUMA ASSOCIATED WITH THIS EVENT. THE PATIENT WAS RECEIVING SUCCESSFUL THERAPY BESIDES THESE ISSUES. NO IMAGING HAD BEEN PERFORMED ON THE SYSTEM. AN IMPEDANCE TEST WAS RUN AT 3.0V AND EVERYTHING APPEARED WITHIN NORMAL LIMITS EXCEPT ELECTRODES 8 AND 9 SHOWING <(><<)>150 OHMS. ELECTRODES 8 AND 9 WERE NOT BEING USED IN PROGRAMMING OR CAUSING PROBLEMS. THE PATIENT WAS PROGRAMMED ON ELECTRODES 3, 4, 5, 6, 7, 12, 14, AND 15. THEY WERE SEEING AN ELECTIVE REPLACEMENT INDICATOR (ERI) MESSAGE ON THE CLINICIAN PROGRAMMER. THE BATTERY VOLTAGE WAS AT 3.77V AND THE PATIENT HAD BEEN RECHARGING MORE FREQUENTLY SINCE 2012. THE PATIENT WAS INDICATED FOR LUMBAR RADICULOPATHY. NO CAUSES, INTERVENTIONS, OR OUTCOME WERE REPORTED WITH THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819320 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR