BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 2781195 · Received October 10, 2012

    Report

    Report Number
    3004209178-2012-09077
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Report Date
    September 12, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 377860, LOT# V017963, IMPLANTED: (B)(6) 2007. PRODUCT TYPE: LEAD: PRODUCT ID 377860, LOT# V009038, IMPLANTED: (B)(6) 2007. PRODUCT TYPE: LEAD: PRODUCT ID 37742, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT WAS NOT ABLE TO ADJUST STIMULATION. THE DEVICE WAS DISPLAYING "CALL YOUR DOCTOR" ICON AND ELECTIVE REPLACEMENT INDICATOR. THE PATIENT VERIFIED THIS WITH BOTH OF THE PATIENT PROGRAMMERS. THERE WAS "POOR COMMUNICATION" SCREEN WHEN SHE ATTEMPTED TO SYNCHRONIZE. SHE FELT AS IF THE STIMULATION WAS "JUMPING" AND THAT SHE HAD INCREASED PAIN BACK DOWN HER LEG TO HER KNEE. THIS HAD OCCURRED THE WEEK PRIOR TO THE DATE OF THIS REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1