BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3072921 · Received April 23, 2013

    Report

    Report Number
    3004209178-2013-06752
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    December 1, 2011
    Report Date
    December 20, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37651, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37092, LOT # 246870001, IMPLANTED: (B)(6) 2010, PRODUCT TYPE ACCESSORY; PRODUCT ID 39565-65, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "ABOUT A YEAR AGO" THE PATIENT WAS UNABLE TO TURN HIS STIMULATION OFF. THE BATTERY WAS FULL AT THAT TIME. SEE MFR 3004209178-2013-00278 FOR A REPORT OF CURRENT ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173270 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 00031 YR