BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 3761240 · Received April 21, 2014

    Report

    Report Number
    3004209178-2014-07556
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Report Date
    March 31, 2014
    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

    CONCOMITANT PRODUCTS: PRODUCT ID 39565-65, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37746, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WORKED BUT IT DID NOT ADDRESS THE CORRECT AREA OF PAIN. IT WAS NOTED THAT THE PATIENT¿S PAIN WAS ¿SOMEWHAT IN A NEW LOCATION BUT SOMEWHAT IN THE SAME LOCATION IT ALWAYS WAS.¿ IT WAS NOTED THAT THE PATIENT HAD PAIN THAT WAS NOT ADDRESSED BY THE IMPLANTABLE NEUROSTIMULATOR (INS) SINCE THEY FELL (B)(6) 2014. IT WAS LATER REPORTED THAT THERE WAS A LOSS OF THERAPEUTIC EFFECT. THE PATIENT NOTED A FALL ¿ABOUT A MONTH¿ PRIOR TO (B)(6) 2014 AND SINCE THAT TIME WAS NOT GETTING THE COVERAGE THAT THEY NEEDED FOR THE ¿BOTTOM OF THEIR BACK.¿ THE PATIENT WAS NOT SURE IF IT WAS NEW PAIN. IT WAS NOTED THAT THE LOW BACK WAS TYPICALLY WHERE THE PATIENT HAD PAIN BUT THE ¿COVERAGE WAS DIFFERENT.¿ THE PATIENT WAS CURRENTLY LOOKING FOR A NEW MANAGING HEALTHCARE PROFESSIONAL (HCP). IT WAS LATER REPORTED THAT THE PATIENT STILL HAD CONCERNS WITH THEIR DEVICE OR THERAPY. IT WAS ALSO NOTED THAT THE PATIENT RECEIVED ASSISTANCE FROM THE DOCTOR OR MANUFACTURER REPRESENTATIVE AND THEIR CONCERNS WERE RESOLVED. NEXT TO APPOINTMENT DATE AFTER THIS RESPONSE ¿TWO YEARS¿ WAS WRITTEN. IT WAS ALSO NOTED THAT THE PATIENT WAS STILL HAVING CONCERNS WITH THEIR DEVICE OR THERAPY BUT WERE WORKING WITH THE DOCTOR OR MANUFACTURER REPRESENTATIVE. NEXT TO APPOINTMENT DATE AFTER THIS RESPONSE ¿TWO YEARS¿ WAS WRITTEN AGAIN. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240674 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR