BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3813591 · Received May 15, 2014

    Report

    Report Number
    3004209178-2014-09047
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    February 22, 2013
    Report Date
    April 17, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER. PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: 2013-(B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S STIMULATOR ¿HAD BEEN MALFUNCTIONING ON AND OFF¿ SINCE THE PATIENT HAD IT. IT WAS STATED THE PATIENT HAD BEEN UNABLE TO GET THE IMPLANTABLE NEUROSTIMULATOR (INS) PROGRAMMED CORRECTLY SINCE IMPLANT. IT WAS NOTED THE PATIENT WAS ON FENTANYL AND PAIN PATCHES AT THE TIME OF REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290709 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 00068 YR