BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3864312 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-11322
    Event Type
    Injury
    Date Received
    June 10, 2014
    Report Date
    June 10, 2014
    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
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3 9565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PROGRAMMER WOULD NOT TURN ON. IT WAS NOTED THAT THE BATTERIES WERE REPLACED BUT "THE SCREEN WILL STILL NOT TURN ON." IT WAS NOTED THAT THIS ISSUE STARTED "A COUPLE WEEKS AGO." ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS REGARDING HER DEVICE BUT WAS WORKING WITH HER HCP OR MANUFACTURER¿S REPRESENTATIVE. IT WAS STATED THAT AN APPOINTMENT HAD BEEN SCHEDULED (B)(6) 2014. IT WAS STATED THAT SHE HAD BEEN ¿ORDERING A NEW ONE¿ WHEN ¿ALL OF A SUDDEN IT JUST WENT ON¿ AND THAT SHE HAS HAD THE "SAME PROBLEMS SINCE." IT WAS STATED THAT THE PATIENT¿S STIMULATION WAS BEING CHARGED ¿EVERY 2 DAYS NOW." THE PATIENT STATED THAT IT LOOKED LIKE A REPLACEMENT WAS ¿COMING SOONER VS. LATER¿ AND THAT THE DEVICE HAD BEEN PUT IN ¿LESS THAN 6 YEARS AGO¿ BUT ¿WHEN HOSPITALIZED IT WAS OFF TOO LONG WHICH IS MOST LIKELY WHY IT NEEDS CHANGING SOON." ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD THE BATTERIES IN BACKWARD. IT WAS STATED THAT THE PROGRAMMER WORKED. IT WAS REPORTED THAT BATTERY STATUS AND IMPEDANCES WERE ALL WITHIN NORMAL LIMITS. IT WAS NOTED THAT THE PATIENT WAS ¿CONSIDERING A REPLACEMENT FOR SENSOR <(>&<)> MRI COMPARABILITY WHEN HER BATTERY REACHES END OF LIFE¿. IT WAS REPORTED THAT THE ¿DEVICE WOULD NOT POWER ON¿ AND "IT" WOULD NOT SYNC. THE ¿REPLACE EXTERNAL STIMULATOR BATTERY SCREEN¿ WAS OBSERVED BUT THE PATIENT WAS USING BRAND NEW BATTERIES. ANALYSIS OF THE PATIENT PROGRAMMER FOUND THAT THERE WAS NO ANOMALY. IT WAS NOTED THAT THE BOTTOM CASE ASSEMBLY WAS WORN AND THE FACE PLATE WAS SCRATCHED. THE ANTENNA JACK WAS RESOLDERED AS A PREVENTATIVE MEASURE. IT WAS LATER REPORTED THAT THE PATIENT RECEIVED ASSISTANCE FROM THE MANUFACTURER REPRESENTATIVE AND THEIR CONCERNS WERE RESOLVED. IT WAS NOTED THAT IN THE APPOINTMENT DATE SECTION THE PATIENT WROTE ¿(B)(6) 2014 FOR BATTERY REPLACEMENT APPOINTMENT.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339803 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 00050 YR Required Intervention