BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 5467522 · Received February 29, 2016

    Report

    Report Number
    3004209178-2016-03640
    Event Type
    Malfunction
    Date Received
    February 29, 2016
    Date of Event
    February 2, 2016
    Report Date
    February 2, 2016
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL DEVICES: PRODUCT ID: 377860, LOT# V011544, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 377760, LOT# V012066, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    THE MANUFACTURER REPRESENTATIVE AND CONSUMER REPORTED THAT IMPEDANCE MEASUREMENTS WERE TAKEN AND ALL PAIRS WITH CONTACTS 0 AND 6 WERE OUT OF RANGE. THE MANUFACTURER REPRESENTATIVE WANTED TO KNOW IF THE IMPEDANCES COULD BE OFF BECAUSE THE BATTERY WAS AT END OF SERVICE (EOS), AND IT WAS REVIEWED THAT THE IMPEDANCE RESULTS SHOULD STILL BE ACCURATE. IT WAS NOTED THAT NORMAL EOS HAD OCCURRED BECAUSE THE PATIENT WAS IMPLANTED IN 2006, AND THE MANUFACTURER REPRESENTATIVE REPORTED THAT THEY WOULD BE REPLACING THE IMPLANTABLE NEUROSTIMULATOR (INS) AS IT HAD REACHED EOS. THERE WERE NO REPORTED PATIENT SYMPTOMS. THE CONSUMER REPORTED THAT THE PATIENT WAS GETTING GOOD STIMULATION, AND THE PATIENT DID NOT HAVE ANY ISSUES AS A RESULT OF THE OUT OF RANGE IMPEDANCES. NO EVENT CAUSE WAS REPORTED FOR THIS EVENT. NO OUTCOME OR FURTHER TROUBLESHOOTING/INTERVENTIONS WERE REPORTED FOR THIS EVENT. FOLLOW UP INFORMATION WAS REQUESTED TO DETERMINE EVENT CAUSE AND ACTIONS/INTERVENTIONS TAKEN TO RESOLVE THE IMPEDANCE ISSUE. ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE AND CONSUMER REPORTED THAT THE PATIENT HAD GOOD PAIN COVERAGE WITH THE SPINAL CORD STIMULATION (SCS), AND THERE WERE NO PLANS TO TOUCH OR REPLACE THE LEADS. THE PATIENT WILL BE SCHEDULED FOR BATTERY REPLACEMENT DUE TO EOS. AS OF 09-FEB-2016, THE MANUFACTURER REPRESENTATIVE DID NOT KNOW THE SCHEDULED DATE FOR THE BATTERY REPLACEMENT PROCEDURE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SENT. THE PATIENTINDICATIONS FOR USE INCLUDED COMPLEX REG PAIN SYNDROME TYPE I.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123693 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00039 YR