BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 5605459 · Received April 25, 2016

    Report

    Report Number
    3004209178-2016-08156
    Event Type
    Injury
    Date Received
    April 25, 2016
    Date of Event
    October 30, 2015
    Report Date
    May 27, 2016
    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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3888-33, LOT# V483090, IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD. PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD. PRODUCT ID: 3888-45, LOT# V508213, IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3888-33, LOT# V483090, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID 3888-45, LOT# V508213, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER'S REPRESENTATIVE (REP) REPORTED THE CONSUMER HAD THEIR FULL SYSTEM REPLACED WITH A NEW SYSTEM. FOLLOWING THIS THE CONSUMER WAS GETTING GOOD STIMULATION OF ALL PAINFUL AREAS AND THE ISSUE WAS RESOLVED.

    Description of Event or Problem · 1

    A CONSUMER IMPLANTED FOR FAILED BACK SURGERY SYNDROME AND CHRONIC LOW BACK PAIN REPORTED VIA THE MANUFACTURER'S REPRESENTATIVE (REP) THEY WERE GETTING GOOD RELIEF OF THEIR PAINFUL AREA UNTIL ABOUT SIX MONTHS AGO, THEN THEY STARTED EXPERIENCING LESS BACK PAIN RELIEF. NO FALLS OR TRAUMAS WERE REPORTED THAT COULD HAVE CAUSED THE CHANGE. IMPEDANCE TESTING WAS PERFORMED WHICH SHOWED OUT OF RANGE RESULTS ON CONTACTS 3, 11, AND 14. REPROGRAMMING WAS ATTEMPTED BUT THE CONSUMER EXPERIENCED SHARP DISCOMFORT WITH THEIR PERIPHERAL LEADS, AND ONLY ABLE TO GET LOWER EXTREMITY STIMULATION WITH THE EPIDURAL LEAD. THE CONSUMER WAS SET-UP WITH A HIGH DEFINITION PROGRAM AND INSTRUCTED ON HOW TO RUN IT. IT WAS UNKNOWN IF THE ISSUE WAS RESOLVED AT THE CURRENT TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258627 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 47 YR Required Intervention