BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3015733 · Received March 21, 2013

    Report

    Report Number
    3004209178-2013-04056
    Event Type
    Malfunction
    Date Received
    March 21, 2013
    Report Date
    March 4, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3998, LOT# V233248, IMPLANTED: (B)(6) 2011. PRODUCT TYPE: LEAD: PRODUCT ID 37752, SERIAL# (B)(6). PRODUCT TYPE: RECHARGER: PRODUCT ID 37743, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011. PRODUCT TYPE: EXTENSION: PRODUCT ID 3550-29, LOT# N277617, IMPLANTED: (B)(6) 2011. PRODUCT TYPE: ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT COULD NOT ADJUST STIMULATION. A POWER-ON-RESET (POR) CONDITION AS REPORTED TO HAVE BEEN DISPLAYED ON THE PATIENT PROGRAMMER. NO DIAGNOSTIC IDENTIFIER FOR THE POR WAS PROVIDED. THE PATIENT USED THE RECHARGER AND "ACTIVE CHARGE" SCREEN WAS SEEN. THE IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY WAS AT 3/4 FULL. THE PATIENT HAD CHARGED SUCCESSFULLY 3 DAYS PRIOR TO CALL. THE POR WAS THEN CLEARED USING THE PATIENT PROGRAMMER, BUT THEN IT APPEARED AGAIN. AFTER PUTTING NEW BATTERIES INTO THE PROGRAMMER, THE REPORTER WAS INSTRUCTED TO CLEAR THE POR AGAIN, BUT A "POOR COMMUNICATION" SCREEN APPEARED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118830 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