BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 3142262 · Received June 3, 2013

    Report

    Report Number
    3004209178-2013-08518
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Report Date
    May 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3550-39, LOT# N295554, IMPLANTED: (B)(6) 2011, PRODUCT TYPE ACCESSORY; PRODUCT ID 3 7743FA, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3550-29, LOT# N243113, IMPLANTED: (B)(6) 2011, PRODUCT TYPE ACCESSORY; PRODUCT ID 3776-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION; PRODUCT ID 37743FA, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WANTED A DIFFERENT PROGRAM ON HER DEVICE. THE REPORTER STATED THAT THE PATIENT HAD FOUR PROGRAMS BUT ¿HER BODY SEEMED TO GET USED TO THEM.¿ IT WAS REPORTED THAT THE PATIENT KNEW HOW TO INCREASE THE STIMULATION, BUT IT WAS ¿MORE THE COVERAGE¿ THAT WAS THE ISSUE. THE PATIENT¿S PAIN WAS IN HER ARMS AND NECK. IT WAS NOTED THAT THE PATIENT GOT MORE RELIEF IN HER ARM AND HAND. IT WAS REPORTED THAT WHEN THE PATIENT WAS INCREASING STIMULATION IT WAS ¿NOT A GOOD FEELING¿ AND WAS ANNOYING. IT WAS LATER REPORTED THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT AND WAS STILL HAVING PAIN IN HER NECK WHICH BEGAN ABOUT ONE MONTH PRIOR TO REPORT AND HAD PROGRESSIVELY GOTTEN WORSE. IT WAS STATED THE PATIENT UNSUCCESSFULLY TRIED TO MAKE ADJUSTMENTS TO HER PROGRAMMER AND WANTED TO HAVE REPROGRAMMING DONE AS ONLY PROGRAMS B AND D ¿WORK FOR HER.¿ IT WAS ALSO STATED THE PATIENT TRIED INCREASING STIMULATION BUT ¿DID NOT HAVE ANY LUCK.¿ IT WAS LATER REPORTED THE PATIENT WAS NOT ABLE TO MAKE ADJUSTMENTS WHEN THE ANTENNA ATTACHED. IT WAS ALSO STATED THE PATIENT HAD TO ¿CONSTANTLY ADJUST STIMULATION FOR PAIN RELIEF BECAUSE THE IMPLANT WAS AT HER NECK AND STIMULATION CHANGED WHEN SHE MOVED AROUND.¿

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PATIENT WAS INCREASING STIMULATION IT WAS BOTHERSOME

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243347 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening