BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 3163067 · Received June 11, 2013

    Report

    Report Number
    3004209178-2013-10164
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Report Date
    May 20, 2013
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37743, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3778-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 3778-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD. (B)(4)

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT "ABOUT A MONTH AGO" THE PATIENT WENT TO THE DOCTOR'S OFFICE AND A MEDTRONIC REPRESENTATIVE CONFIRMED THAT HER INS WAS DEPLETED. THE PATIENT CALLED THE DOCTOR'S OFFICE AND THEY SAID THEY WERE WAITING FOR AN OPENING FOR SURGERY.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT COMPATIBILITY GUIDELINES WERE REQUESTED FOR THE FOLLOWING: MRI. IT WAS NOTED THAT THE DEVICE HAD BEEN OFF FOR 6 WKS. THEY HAD BEEN TRYING TO SCHEDULE APPOINTMENT TO HAVE BATTERY REPLACED. THE REPORTER WANTED TO KNOW HOW TO CONFIRM INS WAS OFF PRIOR TO DOING MRI. IT WAS NOTED THAT THE PATIENT PROGRAMMER WASN'T WORKING. THE REPORTER GOT THE PATIENT PROGRAMMER AND COULDN'T GET IT TO TURN ON. THE REPORTER TRIED BATTERIES FOUND AT THE OFFICE-THOSE DIDN'T WORK. THEY TRIED THE ORIGINAL SET AND THE PATIENT PROGRAMMER POWERED UP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS NOT EXPERIENCING STIMULATION SENSATION. THE PATIENT TURNED THE STIMULATOR ON 6 WEEKS TO A MONTH PRIOR TO THE DATE OF THIS REPORT AND WAS NOT ABLE TO FEEL STIMULATION. THE PATIENT USUALLY FELT STIMULATION WHEN SHE PUT HER HAND OVER HER HEAD. THE PATIENT HAD NOT FELT STIMULATION ¿IN A WHILE.¿ THE PATIENT WAS UNABLE TO ADJUST STIMULATION. THE PATIENT PROGRAMMER DISPLAYED, ¿CALL YOUR DOCTOR.¿ THE PATIENT SAW THE ELECTIVE REPLACEMENT INDICATOR (ERI) MESSAGE THE DAY BEFORE THIS REPORT. IT WAS ALSO NOTED THAT THE PATIENT HAD TWO EYE SURGERIES IN THE LAST MONTH. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION NOTED THE PATIENT HAD TURNED THEIR STIMULATION ON AND NEVER FELT STIMULATION. IT WAS NOTED THE PATIENT TRIED TO TURN THE STIMULATOR ON YESTERDAY AND IT DID NOT COME ON. IT WAS REPORTED THE PATIENT SAW THE POOR COMMUNICATION SCREEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263581 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR