BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 3202925 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-11237
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    April 11, 2013
    Report Date
    June 11, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ERROR CODE STATING "INVALID SETTINGS HAVE BEEN DETECTED, ALL SETTINGS WILL BE CLEARED (18, 2) WAS SEEN ON THE CLINICIAN PROGRAMMER. ALL PROGRAMMING WAS CLEARED. IT WAS NOTED THAT THE PATIENT HAD NOT BEEN TO THE AIRPORT OR HAD ANY TESTS. THE LAST PROGRAMMING SESSION WAS IN MARCH AND THE PATIENT WAS GIVEN GROUP B FOR HIS BACK AND HAD IT FOR ABOUT ONE MONTH BEFORE HE LOST THAT GROUP. THE PATIENT PROGRAMMER WAS USED TO INTERROGATE THE DEVICE AND IT WAS CONFIRMED THAT ONLY GROUPS A, C AND D WERE PRESENT. THE DEVICE WAS INTERROGATED AGAIN AND THE CODE WAS BYPASSED AND ALL PROGRAMS WERE LOST. THE DEVICE SERIAL NUMBER WAS PRESENT AND THE IMPLANT DATE WAS STILL PRESENT AND ACCURATE. THE LEAD INFORMATION WAS GONE AND THE PATIENT INFORMATION WAS GONE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    NO FURTHER INFORMATION WAS PROVIDED ABOUT THE ERROR SCREEN SEEN ON THE CLINICIAN PROGRAMMER. IT WAS NOTED THAT THE PATIENT WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302382 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00092 YR