BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 6284497 · Received January 27, 2017

    Report

    Report Number
    3004209178-2017-01984
    Event Type
    Malfunction
    Date Received
    January 27, 2017
    Date of Event
    January 25, 2017
    Report Date
    March 31, 2017
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 3776-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3487A-45, LOT# V125952, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3487A-45, LOT# V078605, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT. IT WAS REPORTED THAT THE PATIENT WAS IN THE OPERATING ROOM (OR) ON THE DATE OF THIS REPORT DUE TO A TRIPOLE CONFIGURATION. DURING PRE-OP, THE PATIENT¿S TWO QUAD LEADS WERE BOTH SHOWING IMPEDANCE VALUES THAT WERE OUT OF RANGE. THEIR OCTAD LEAD WAS FINE, WHICH IS WHAT THE PATIENT WAS USING AND HAD GREAT COVERAGE WITH. WHEN CONNECTING THE LEAD TO THE IMPLANTABLE NEUROSTIMULATOR (INS), ALL IMPEDANCES WERE OUT OF RANGE AND THE PATIENT WASN¿T FEELING ANY STIMULATION. THE PHYSICIAN WIPED AND RE-INSERTED THE LEAD ABOUT 2-3 TIMES WITH THE SAME RESULT. ON THE LAST ATTEMPT, THE PHYSICIAN WIPED, RECONNECTED, AND REPROGRAMMED THE LEAD CONFIGURATION; 4-8-4 WITH THE OCTAD LEAD IN THE 8-15 SLOT AND THE BIFURCATED EXTENSION WAS ON THE 0-7 PORT. THE MANUFACTURER REPRESENTATIVE REPORTED THAT ALL IMPEDANCES WERE WITHIN NORMAL LIMITS AND THE PATIENT WAS FEELING STIMULATION/COVERAGE WHERE THEY NEEDED IT. TROUBLESHOOTING RESOLVED THE REPORTED ISSUE.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) INDICATED FOR FAILED BACK SURGERY SYNDROME. IT WAS REPORTED THAT ALL CONTACTS WERE OVER 10,000 OHMS WHEN RUNNING IMPEDANCES AT .7V. RE-RUNNING THEM AT 3V OBSERVED: 1-5122, 2-3255, 3<150, 4 THROUGH 7>40,000, 8-23045, 9-27295, 10-24498, 11-23392, 12-23749, 13-23749, 14-27783, 15-26594. THE IMPLANT WAS ON. THE PATIENT WAS GETTING GOOD THERAPY WITH AMPLITUDE SET AT 7.5V AND 7.4 V. THE PATIENT INCREASED THROUGHOUT THE DAY AND WAS PROGRAMMED ON 11, 13, 15, AND THEN ON 14 AND 15. NO RELATED PATIENT SYMPTOMS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE. IT WAS REPORTED THAT THE CAUSE OF THE PRE-OPERATIVE OUT OF RANGE (OOR) IMPEDANCES WERE UNKNOWN. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE REPRESENTATIVE REPORTED THAT PATIENT WEIGHT WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65514 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 51 YR