BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3782107 · Received April 30, 2014

    Report

    Report Number
    3004209178-2014-08309
    Event Type
    Injury
    Date Received
    April 30, 2014
    Report Date
    April 17, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3587A25, LOT # N363119, IMPLANTED: (B)(6) 2013; PRODUCT TYPE LEAD; PRODUCT ID 3587A25, LOT # N305748, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3587A25, LOT # N287219, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3587A25, LOT # N363119, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3708260, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 3708260, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 3708260, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 3708260, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IN A LOT OF PAIN AND WAS STILL TRYING TO FIND SETTINGS TO HELP THE PATIENT¿S PAIN SYMPTOMS. THE PATIENT UNDERSTOOD THAT THERAPY WOULD HELP REDUCE PAIN BY 50% AND THE PATIENT WAS STILL GOING TO NEED TO LEARN HOW TO MANAGE THEIR PAIN. IT WAS NOTED THAT THE PATIENT WAS SCHEDULED TO HAVE A NERVE BLOCK TRIGEMINAL NERVE TOMORROW, NOT RELATED TO THE PAIN STIMULATION THERAPY, AND COMPATIBILITY GUIDELINES WERE REQUESTED. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD A MOTOR CORTEX IMPLANTABLE NEUROSTIMULATOR (INS). THE REPORTER STATED THE PATIENT HAD ATYPICAL FACIAL PAIN AND ¿THEIR ENVIRONMENT WAS TOUCH, NOISE, WARM, OR COLD.¿ THE REPORTER FURTHER STATED THAT IF THEY PATIENT WENT TO THEIR ¿ENVIRONMENT¿ THEIR PAIN LEVEL GOES DOWN TO 4 AND IF THE PATIENT GOES OUTSIDE OF THEIR ¿ENVIRONMENT¿ THE PAIN LEVEL GOES UP TO 8. IT WAS NOTED THE REPORTER STATED THE PATIENT¿S HEALTHCARE PROFESSIONAL (HCP) WAS THE ONLY PERSON THAT DOES THE PATIENT¿S INS. IT WAS FURTHER NOTED THE PATIENT HAD EPILEPSY. THE REPORTER STATED THE PATIENT WAS THE FIRST ONE EVER TO ¿DO IT WITH EPILEPSY.¿ THE REPORTER FURTHER STATED THE HCP PUT DEEP BRAIN STIMULATION IN THEIR NOTES, BUT THEY DID NOT PUT IN THEIR NOTES THAT THE PATIENT WAS USING IT IN THEIR OFFICE. THE REPORT FURTHER STATED THE PATIENT FROM 5.5 TO 2.5 SO WOULD THAT CASE THE SEIZURES OR WOULD IT BE THE VOLTAGE. IT WAS NOTED THE PATIENT HAD THE MEDICAL CONCERNS FOR ABOUT THREE YEARS. IT WAS FURTHER NOTED THE PATIENT HAD MADE 21 TRIPS SINCE IMPLANT TO GET THE INS ADJUSTED. THE REPORTER STATED THE PATIENT¿S HCP WAS THE ONLY HCP IN THE WORLD THAT COULD MAKE ADJUSTMENTS TO THE PATIENT¿S INS. THE REPORTER FURTHER STATED THEY WERE NOT GETTING ANY COOPERATION AND THE HCP DID THE SURGERY, DEVELOPED IT FROM 8 LEADS TO 16 LEADS, AND MADE THE CONFIGURATION. IT WAS NOTED THE HCP STATED THE PATIENT WOULD FEEL BETTER IN A WARMER CLIMATE BECAUSE THEY SEE LESS PATIENTS IN WARMER CLIMATES THAN ONES THAT LIVE IN A COLDER CLIMATE. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260251 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 Other