BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE PRIME

    MDR report key: 2823435 · Received November 8, 2012

    Report

    Report Number
    3004209178-2012-10029
    Event Type
    Malfunction
    Date Received
    November 8, 2012
    Report Date
    October 11, 2012
    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

    PRODUCT ID, 3889-28 LOT# VA005RZ, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 37744 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 3708220 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT OBSERVED A "CALL YOUR DOCTOR" ICON WITH AN ELECTIVE REPLACEMENT INDICATOR (ERI) SEEN ON THEIR PROGRAMMER COMPONENT OF THEIR IMPLANTABLE NEUROSTIMULATOR (INS). THE ERI WAS NOTED TO HAVE BEEN SEEN FOR A "COUPLE MONTHS". IN ADDITION, THE PATIENT STATED THAT SHE WAS ON MEDICATIONS DUE TO 6 SURGERIES IN THE LAST 2 TO 3 MONTHS BUT IT WAS UNCLEAR IF THE SURGERIES WERE RELATED TO THE INS SYSTEM. ALSO, THE PATIENT REPORTED THEY BECAME "SEPTIC AND INFECTED" BUT NOTED THAT THIS HAD NOTHING TO DO WITH THEIR INS DEVICE. THE PATIENT HAD AN APPOINTMENT WITH THE COMPANY REPRESENTATIVE ON (B)(6) 2012. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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 Required Intervention