BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 4241348 · Received November 10, 2014

    Report

    Report Number
    3004209178-2014-21253
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Report Date
    October 15, 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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37092, SERIAL# UNKNOWN, PRODUCT TYPE: ACCESSORY. PRODUCT ID: NEU_PTM_PROG, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3550-29, LOT# N335559, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_ENS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE: EXTERNAL NEUROSTIMULATOR. PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT DID NOT HAVE CONCERNS WITH THE DEVICE OR THERAPY. IT WAS NOTED THAT THE PATIENT RECEIVED ASSISTANCE FROM THE HEALTH CARE PROFESSIONAL OR MANUFACTURING REPRESENTATIVE AND THE CONCERNS WERE RESOLVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2014, THE PATIENT HAD TO TURN OFF HER IMPLANTABLE NEUROSTIMULATOR (INS) WHILE THEY DID ANOTHER TRIAL. THE CURRENT INS WAS IMPLANTED IN THE PATIENT¿S CHEST AND WAS FOR HER FACE. THE CURRENT INS WAS ONLY WORKING ON A SMALL SECTION OF THE FACE. THE TRIAL WAS TO DETERMINE IF ANOTHER INS WAS NEEDED TO REACH THE OTHER PORTION OF HER FACE. IT WAS NOTED THE PATIENT WAS IN A LOT PAIN. THE PATIENT NOTICED THE INCREASE IN PAIN ON (B)(6). IT WAS ALSO REPORTED THAT THERE WAS A PROBLEM WITH THE PATIENT PROGRAMMER (PP) WHICH STARTED ON (B)(6) 2014. THE PATIENT WAS UNABLE TO MAKE ADJUSTMENTS WITH THE ANTENNA ATTACHED, THE ANTENNA WAS DAMAGED, THE PATIENT WAS SEEING A MESSAGE ON HER PP INDICATING THE BATTERIES NEEDED TO BE CHANGED, AND THERE WAS NO TELEMETRY WITH THE ANTENNA. THE ANOMALY APPEARED TO HAVE OCCURRED THROUGH PRODUCT USE. NO INDICATION OF PATIENT HARM. NO DEVICE RETURNED. C500. UPON DEVICE RETURN OF THE PP, ANALYSIS FOUND THE ANTENNA JACK WAS RESOLDERED AS PREVENTATIVE MEASURE. C200. ON (B)(6) 2014, IT WAS REPORTED THE PATIENT WAS IN EXTREME PAIN DUE TO NOT BEING ABLE TO ADJUST STIMULATION AND STIMULATION WAS TOO HIGH. IT WAS NOTED THE PATIENT WAS NOT ABLE TO SLEEP THE NIGHT PRIOR TO THE REPORT DUE TO THE PAIN. BASIC FUNCTIONALITY WAS REVIEWED WITH THE PATIENT ON APPROPRIATE BATTERIES TO USE, SYNCHING, AND HOW TO ATTACH AND DETACH THE ANTENNA. IT WAS NOTED THE PATIENT WAS HAVING SOME TROUBLES WITH THE NEUROSTIMULATOR, BUT IT WAS THEN VERIFIED THE ISSUE WAS NOT WITH THE STIMULATOR, BUT THE PP. THE PROBLEMS WITH THE PP HAD BEEN OCCURRING SINCE (B)(6) 2014. THE PP HAD NOT GOTTEN WET OR DROPPED. THE PATIENT WOULD HIT THE SYNC BUTTON, THE MANUFACTURER¿S SYMBOL AND 9.0 WOULD FLASH AND THEN IT WOULD SHOW A PICTURE TO HIT THE SYNC BUTTON AGAIN AND THE SAME THING WOULD HAPPEN. THE PATIENT CHANGED THE BATTERIES LAST (B)(6) AND THE MANUFACTURER¿S SCREEN AND 9.0 FLASHED ON, BUT WOULD NOT CONNECT TO THE IMPLANTABLE NEUROSTIMULATOR (INS). THE BATTERIES WERE CHANGED AGAIN THE DAY OF THE REPORT AND THE PROGRAMMER WOULD SHOW TO ADJUST THE ANTENNA AND IT WOULD STILL NOT CONNECT. THE PATIENT UNPLUGGED THE ANTENNA FROM THE PP AND WAS ABLE TO CONNECT TO THE INS AND WAS ABLE TO DECREASE THE STIMULATION. AFTER STIMULATION WAS DECREASED, THE PATIENT WAS NOT IN AS MUCH PAIN AND HER BODY WAS ABLE TO RELAX AND SHE FELT LIKE SHE MAY BE ABLE TO SLEEP. IT WAS NOTED THE DECREASED PAIN SHE WAS CURRENTLY FEELING MAY HAVE BEEN BECAUSE OF THE HIGH STIMULATION SHE WAS GETTING YESTERDAY. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723195 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1