BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3934682 · Received July 15, 2014

    Report

    Report Number
    3004209178-2014-13011
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 20, 2013
    Report Date
    June 20, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 37702, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3550-39, LOT# N234318, IMPLANTED: (B)(6) 2010, PRODUCT TYPE ACCESSORY; PRODUCT ID 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT NEITHER OF THE PATIENT¿S STIMULATORS HAD BEEN WORKING FOR THE PAST YEAR. THE PATIENT DID HAVE A RECHARGER, BUT SHE HAD SOME DEMENTIA AND IT WAS UNKNOWN WHEN SHE RECHARGED OR HOW OFTEN. THE PATIENT WAS REDIRECTED TO HER PHYSICIAN TO HAVE HER DEVICE RESTARTED AND TO CHECK THE STATUS. ADDITIONAL INFORMATION WAS REQUESTED, IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT. SEE MFR 3004209178-2014-13010 FOR THE PATIENTS SECOND (BILATERAL) DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413516 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 00087 YR