BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2893231 · Received January 2, 2013

    Report

    Report Number
    3004209178-2013-00041
    Event Type
    Malfunction
    Date Received
    January 2, 2013
    Report Date
    December 10, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009. PRODUCT TYPE: LEAD: PRODUCT ID 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009. PRODUCT TYPE: LEAD: PRODUCT ID 37752, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 37743, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 37092, LOT# 215040001, IMPLANTED: (B)(6) 2009. PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A POR (POWER ON RESET) CONDITION WITH THE RECHARGER, FIRST NOTICED THE DAY PRIOR TO THE REPORT. THE REPORTER STATED THAT THE DEVICE WAS LAST RECHARGED 15 DAYS AGO. IT WAS NOTED THAT PRESSING THE AUDIO KEY RESOLVED THE ISSUE AND A REGULAR RECHARGE SCREEN APPEARED, WHICH SAID THE DEVICE WAS 3/4 FULL. IT WAS REPORTED THAT STIMULATION WAS NOT ABLE TO BE ADJUSTED. THE REPORTER STATED THAT THE DISPLAY ON THE PATIENT PROGRAMMER SHOWED THE "CALL YOUR DOCTOR" ICON AND A POR CONDITION. THE POR WAS CLEARED, WHICH RESOLVED THE ISSUE. IT WAS LATER REPORTED THAT THE CAUSE OF THE EVENT WAS UNKNOWN AND A MESSAGE ABOUT DIFFICULTY WITH THE DEVICE HAD BEEN LEFT FOR THE PATIENT'S HEALTH CARE PROVIDER (HCP). THE PATIENT'S HCP HAD NOT BEEN ABLE TO MAKE CONTACT WITH THE PATIENT. IT WAS NOTED THAT THE PATIENT HAD BEEN "LOST TO FOLLOW UP" WITH THE HCP SINCE 2009. A FOLLOW-UP REPORT WILL BE MADE IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    921 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