BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE PRIME

    MDR report key: 3900732 · Received June 27, 2014

    Report

    Report Number
    3004209178-2014-12235
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Report Date
    June 4, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: 2011-(B)(6), PRODUCT TYPE LEAD. PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: 2011-(B)(6), PRODUCT TYPE LEAD. PRODUCT ID NEU_PTM_PROG, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LOSS OF THERAPEUTIC EFFECT. IT WAS STATED THAT THE PATIENT ¿SOMETIMES HAD PROBLEMS WITH THE DEVICE.¿ IT WAS NOTED THAT THE ISSUE HAD STARTED 8-9 MONTHS AGO. IT WAS STATED THAT THE PATIENT DID NOT USE HIS DEVICE AND THE STIMULATION WAS TURNED OFF. IT WAS NOTED THAT THE PATIENT WAS NOT SURE WHEN HE HAD TURNED HIS STIMULATION OFF. IT WAS STATED THAT THE DEVICE WAS NOT WORKING AND THE PATIENT COULDN¿T GET IT TO DO WHAT HE WANTED IT TO DO. IT WAS NOTED THAT THE LAST TIME HE HAD MET WITH SOMEONE TO HELP WAS ABOUT A YEAR AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377759 RESTORE PRIME STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37701

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR