BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 3142237 · Received June 3, 2013

    Report

    Report Number
    3004209178-2013-08516
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Report Date
    May 23, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37743 LOT# SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 39565-65 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) HAD MOVED. IT WAS NOTED THAT THE PATIENT NOTICED THIS ABOUT 2 WEEKS PRIOR TO THE REPORT. IT WAS NOTED THAT THE PATIENT¿S DEVICE WAS IMPLANTED BETWEEN HER BUTTOCKS AND RIGHT LEG, BUT IT HAD MOVED UP. IT WAS NOTED THAT THE PATIENT ¿CAME HOME ONE DAY AND WAS ILL¿ AND SHE ¿JUST SAT ON THE COUCH¿ AND WAS ABOUT TO PASS OUT. IT WAS NOTED THAT THE PATIENT WAS IN PAIN. IT WAS NOTED THAT THE PATIENT DID NOT CONTACT THE DOCTOR ABOUT FEELING ILL, BUT SHE WAS WORKING WITH THE ¿LOCALS.¿ IT WAS FURTHER NOTED THAT THE PATIENT HAD AN APPOINTMENT WITH HER PHYSICIAN, BUT THAT HER INS WAS NOT ¿TOUCHED.¿ IT WAS NOTED THAT THE PATIENT WAS ABLE TO FEEL STIMULATION. ADDITIONAL INFORMATION REPORTED THAT THE PATIENT¿S DEVICE WAS AT END OF LIFE (EOL). IT WAS NOTED THAT THE PATIENT WAS EXPERIENCING A COGNITIVE DECLINE AND IT WAS ¿VERY LIKELY¿ THAT THE PATIENT WOULD NOT HAVE THE INS REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD ¿RUNNING PRESSURE¿ AND PAIN IN THE BACK OF BOTH HIPS. IT WAS NOTED THE PATIENT¿S DEVICE WAS IMPLANTED PERFECTLY ON THE RIGHT SIDE AND WAS NOT IN THE WAY. IT WAS REPORTED THE DEVICE WAS MOVED TO THE OTHER SIDE. IT WAS NOTED THE PATIENT DIDN¿T KNOW WHY THE DEVICE WAS MOVED OR IF IT EVEN WAS MOVED AT ALL. IT WAS REPORTED BOTH OF THE PATIENT¿S SIDES WERE BULGING FOR A COUPLE OF WEEKS PRIOR TO THE CALL. IT WAS NOTED THE PATIENT WAS HAVING THEIR MEDICAL ISSUES ADDRESSED. THE PATIENT¿S STATUS WAS LISTED AS ¿UNDETERMINED.¿

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD PAIN. IT WAS NOTED THAT ONE YEAR PRIOR TO REPORT THE PATIENT WAS HAVING PAIN AND MET WITH A MANUFACTURER REPRESENTATIVE TO HAVE THE DEVICE CHECKED. IT WAS LOGGED THAT THAT PAIN BEGAN ABOUT ONE YEAR PRIOR TO REPORT. IT WAS REPORTED THE PATIENT WAS HAVING PROBLEMS WITH THE DEVICE AND ABOUT A YEAR PRIOR TO REPORT THE PATIENT STARTED HAVING INCREASED PAIN. IT WAS REPORTED THAT AT THAT TIME THE MANUFACTURER REPRESENTATIVE DID A DEVICE CHECK AND THEN THE PAIN WENT AWAY AND THE PATIENT DID NOT WANT TO DEAL WITH THE ISSUE. IT WAS LOGGED THAT STARTING ONE WEEK PRIOR TO THE REPORT THE PATIENT'S PAIN STARTED INCREASING AND SHE HAD SEVERE PAIN IN HER BACK SIDE AND LEGS. IT WAS LOGGED THE PATIENT WANTED TO HAVE THE DEVICE CHECKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244635 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR