BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 3231902 · Received July 17, 2013

    Report

    Report Number
    3004209178-2013-11898
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Report Date
    June 28, 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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37744, SERIAL# (B)(4): PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3776-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012: PRODUCT TYPE LEAD; PRODUCT ID 3776-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012: PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF NEUROSTIMULATOR MODEL 37702, SERIAL # (B)(4), SHOWED NO SIGNIFICANT ANOMALIES AND WAS AT NORMAL END-OF-LIFE (EOL) STATUS. IT WAS NOTED THAT TELEMETRY AND OUTPUT ON THE DEVICE WERE ¿OKAY¿.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT NO MALFUNCTIONS WERE SEEN OR CAUSE OF ISSUE DETERMINED. THE STIMULATOR WAS REPLACED DUE TO ERI. FIVE DAYS LATER IT WAS REPORTED THAT NO MALFUNCTIONS WERE SEEN UPON EXPLANTING THE INS (IMPLANTABLE NEUROSTIMULATOR). THE PATIENT WAS RECEIVING GOOD THERAPY AFTER THE REPLACEMENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE REPLACEMENT WAS NOT YET SCHEDULED AND THE PATIENT WAS DOING FINE.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT HAD BEEN SEEING THE ERI MESSAGE FOR A FEW DAYS PRIOR TO THE REPORT. IT WAS STATED THAT SHE WAS FEELING A BURNING SENSATION ON THE RIGHT LEG FOR THE FIRST TIME AND THAT SHE HAD NEVER FELT IT BEFORE. IT WAS REPORTED THAT THE BURNING SENSATION STARTED ON THE DAY OF THE REPORT. IT WAS STATED THE PATIENT TURNED HER STIMULATION DOWN BECAUSE IT WAS UNCOMFORTABLE WITH THE BURNING SENSATION. THREE DAYS LATER IT WAS REPORTED THAT THE PATIENT WANTED TO RULE OUT THAT HER MOVE TO TRAILER PARK AND SOMETHING BEHIND HER TRAILER KNOWN AS UW RADIATION BUILDING/BUSINESS WAS THE CAUSE OF WHAT SHE WAS EXPERIENCING AND THAT THERE WAS JOLTY/BURNING STIMULATION. IT WAS STATED THAT THE IMPEDANCES WERE ALL GOOD/NORMAL AND THAT ERI CORRESPONDED WITH HER MOVE TO TRAILER PARK. AT THE TIME OF THE REPORT IT WAS UNKNOWN WHAT PATIENT'S AMPLITUDE WAS, BUT SHE RAN 1 PROGRAM DOUBLE GUARDED CATHODE, 450US, 55HZ. THE PATIENT HAD USED IMPLANT TOTAL OF 11,000HRS AND 100% ON 24HR/DAY. THE PATIENT JUST USED ONE LEAD. LONGEVITY CALCULATION WAS PERFORMED TO ESTIMATE INS (IMPLANTABLE NEUROSTIMULATOR) BATTERY LIFE USING 550 OHMS AND ABOVE PARAMETERS/SETTINGS. WITH 3.0V, THE ESTIMATE WAS 33 MONTHS, AND WITH 6.0V - 13 MONTHS. IT WAS STATED THAT PATIENT'S STIMULATION WAS AROUND 5.0V, SO PATIENT'S 15 MONTHS BATTERY LIFE ESTIMATE DIDN'T APPEAR OUT OF LINE ACCORDING TO THE REPORTER. IT WAS STATED THE ERI HAPPENED AT THE SAME TIME OF "JOLTY/STIMULATION," BURNING SYMPTOMS. MORE THAN ONE WEEK LATER IT WAS REPORTED THAT DIAGNOSTICS PERFORMED INCLUDED IMPEDANCE TESTING AND REPROGRAMMING. THE USE OF THE INS WAS BELIEVED TO BE NORMAL. IT WAS STATED THAT THE REPLACEMENT WAS BEING PLANNED. PATIENT'S OUTCOME WAS NOTED AS NO STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331535 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR