BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 2821402 · Received November 6, 2012

    Report

    Report Number
    3004209178-2012-09956
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Report Date
    October 9, 2012
    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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37742, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID *UNK-LD, SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID *UNK-LD, SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS CHARGING MORE THAN EXPECTED AND HAD BEEN HAVING ISSUES WITH HER SYSTEM FOR ABOUT SIX MONTHS. THE PATIENT WAS CONCERNED HER DEVICE BATTERY WAS DEPLETING AND INDICATED THE DEVICE WAS SHUTTING OFF, WHICH THE PATIENT HAD TO MANUALLY TURN BACK ON. THE PATIENT HAD TWO PROGRAMS, WITH THE HIGHEST SETTING ABOUT 7 VOLTS. THE PATIENT RECHARGED LAST NIGHT AND NOW TODAY THE DEVICE WAS SHOWING A QUARTER FULL. THE PATIENT SAW HER DEVICE BATTERY FULL BUT COULD NOT CONFIRM IF SHE SAW THE CHARGE SUFFICIENT OR CHARGE COMPLETE SCREEN. IT WAS NOTED THAT WHEN THE PATIENT USED HER RECHARGER TO TURN THE DEVICE OFF AND THEN BACK ON AGAIN, SHE WOULD GET A 'SHOCK' THAT GAVE HER 'GOOSE BUMPS' WHEN THE STIMULATION COMES BACK ON. USING THE PATIENT PROGRAMMER, THE PATIENT WAS ABLE TO TURN THE DEVICE ON/OFF AND WAS ABLE TO CONFIRM HER HIGHEST AMPLITUDE WAS SET AT 6.2 VOLTS. IT WAS ALSO NOTED THAT THE PATIENT HAD NOT DEALT WITH HER DEVICE DUE TO OTHER HEALTH ISSUES, INCLUDING LUPUS, FIBROMYALGIA, AND DEGENERATIVE BONE DISEASE. THE PATIENT ALSO HAD TUMORS REMOVED FROM HER SINUSES AND THROAT. THE PATIENT HAD PAIN IN SO MANY PLACES AND WANTED THE DEVICE TO WORK. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, AN SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1