BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3567847 · Received January 10, 2014

    Report

    Report Number
    3004209178-2014-00499
    Event Type
    Malfunction
    Date Received
    January 10, 2014
    Report Date
    December 18, 2013
    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

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37744, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A POCKET REVISION PROCEDURE, IMPEDANCE READINGS ¿KEPT CHANGING¿ AND WHILE THE PATIENT WAS IN RECOVERY THEY WEREN¿T GETTING STIMULATION ON THE LEFT SIDE BUT IMPEDANCES WERE ¿FINE¿ (BELOW 4K). IT WAS NOTED THAT THE MANUFACTURER¿S REPRESENTATIVE TRIED CHANGING PARAMETERS/CONTACTS TO SEE IF THERAPY COULD BE ADJUSTED. IT WAS STATED THAT IMPEDANCES THEN SHOWED HIGH ON 9, 10, AND 15. IT WAS NOTED THAT THE LEAD ITSELF WASN¿T TESTED BY ITSELF DURING THE PROCEDURE BECAUSE IT WAS ¿JUST POCKET REVISION¿ AND SINCE THE ISSUE APPEARED TO HAVE ¿RESOLVED¿ INTRAOPERATIVELY. IT WAS STATED THAT THE REPRESENTATIVE ¿MAXED OUT¿ STIMULATION ON THE LEFT LEAD AND WAS USING ALL BUT TWO ELECTRODES BUT THE PATIENT WASN¿T FEELING STIMULATION YESTERDAY. IT WAS STATED THAT THE REPRESENTATIVE WAS ON HER WAY TO THE CLINIC TO MEET WITH THE PATIENT AND TO ASSESS FURTHER. FURTHER INFORMATION WOULD BE ADDED AS IT WAS RECEIVED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT IMPEDANCES ARE OUT OF RANGE WHEN TAKEN AT 0.7V POST REVISION. IT WAS REPORTED THAT THE ELECTRODE IMPEDANCE VALUES WERE OBTAINED AT THE TIME OF THE CALL: 89 5004 810 5445 811 2374 812 2307 813 2586 814 1869 815 >10000 98 5004 910 >10000 911 7265 912 7233 913 7583 914 6771 915 >10000 IT WAS STATED THAT THE 0-7 LEAD SHOWED VERY GOOD VALUES (AROUND 1048 OHMS) AND PATIENT FELT STIMULATION ON THAT PROGRAMMED LEAD. IT WAS STATED THAT ¿THEY HAD CONFIRMED THE ISSUE¿ AND THAT A REVISION WAS PLANNED FOR NOON TOMORROW. IT WAS NOT CLEARLY STATED WHAT THE ISSUE WAS IN THIS REPORT BUT THAT IT WAS RELATED TO LEAD/INS CONTACT SEATING/ALIGNMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20385 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR