BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMEADVANCED

    MDR report key: 3308758 · Received August 26, 2013

    Report

    Report Number
    3004209178-2013-15181
    Event Type
    Malfunction
    Date Received
    August 26, 2013
    Report Date
    August 1, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3708260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3986A, LOT# N241977, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 3986A, LOT# N241977, IMPLANTED: (B)(6) 2010, EXPLANTED: PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT COMPATIBILITY GUIDELINES WERE REQUESTED FOR THE FOLLOWING: MRI. THE AREA TO BE SCANNED WAS STOMACH AREA. CT'S HAD NOT PROVIDED ENOUGH INFORMATION. COMPATIBILITY GUIDELINES WERE REQUESTED FOR THE FOLLOWING: AIRPORT SECURITY SCREENING DEVICES. THE PATIENT WAS EXPERIENCING AN OVERSTIMULATION SENSATION WHEN TURNING THEIR HEAD. STIMULATION IN THE WRONG LOCATION WAS NOTED; SOMETIMES FELT STIM IN LEGS. THE PATIENT WAS EXPERIENCING A SHOCKING OR JOLTING SENSATION. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS ISSUE. LOCATION OF THE PATIENT'S SYMPTOMS WAS NOTED AS: SHOULDERS, HEAD, NECK, LEFT ARM, AND RIGHT ARM. MRI WAS NEEDED BECAUSE THE PATIENT ALSO HAD CROHN'S DISEASE AND THE DOCTOR NEEDED TO SEE HER KIDNEYS. IT WAS NOTED THE PATIENT: "HAVE DEALT WITH A LOT SINCE 1995." THE PATIENT HAD RSD (REFLEX SYMPATHETIC DYSTROPHY) AND THE INS IS FOR THEIR UPPER BODY AND SPREADS OUT INTO THEIR SHOULDERS. IT WAS NOTED: "LEADS GO OUT INTO MY SHOULDERS." INS WAS LOCATED IN THE HIP. REGARDING IF THE INS COVERED THE PAIN, IT WAS NOTED: "IT CAN AT CERTAIN TIMES." EVEN THOUGH THE LEADS WERE IN THE UPPER EXTREMITIES, "IT CAN ALSO CAUSE THE FEELING IN MY LEGS. IF IT'S UP HIGH ENOUGH TO COVER WHAT I FEEL IN THE UPPER, BUT MY LEGS HAVE A MIND OF THEIR OWN. THEY KIND OF GO WHIPPITY WHOP SO I NEVER USE IT WHEN I'M TRYING TO WALK". IT WAS NOTED THE INS WAS "STRICTLY FOR SIT DOWN AND WHEN MY THERAPIST USES IT WHILE HE'S TRYING TO STRAIGHTEN OUT MY FINGERS BECAUSE MY FINGERS ARE ALL CRAMPED UP. IF I MOVE MY HEAD A CERTAIN WAY, I HAVE A REFLEX." IT WAS NOTED THAT ONE TIME WHILE THE THERAPIST WAS WORKING WITH HER FINGERS, THE PATIENT TURNED HER HEAD "AND ALL OF A SUDDEN MY HAND WAS IN HIS FACE." IT WAS NOTED THAT BECAUSE THEIR LEGS HURT TOO, THE THERAPIST HAD THEM KEEP THE INS ON ONE DAY WHILE WALKING. THE PATIENT TURNED THEIR HEAD AROUND TO SEE HOW FAR SHE HAD WALKED "AND MY WHOLE BODY SPUN AROUND IN A CIRCLE." "I DID A 360." THE THERAPIST SAID THAT IN THE FUTURE, THEY WILL NOT HAVE THE INS ON WHILE WALKING. IT WAS NOTED THAT EVEN IF THEY ARE SITTING DOWN AND HAVE THE STIM AT A CERTAIN LEVEL AND TURNS THEIR HEAD RIGHT OR LEFT, "IT WILL ACTUALLY ZOOM UP ON ITS OWN." THE DOCTOR WAS AWARE OF THIS AND A MANUFACTURER'S REPRESENTATIVE ADJUSTED THE INS. THE REPRESENTATIVE ADJUSTED THE STIM SO IT WAS FELT "MORE IN THE AREA I NEEDED IT...BUT I STILL GET THAT JOLT WHEN I TURN MY HEAD." THE JOLT HAS NOT BEEN DEALT WITH DUE TO OTHER MEDICAL ISSUES. IN 2013 THE PATIENT HAD HAD OTHER HEALTH ISSUES. THE RSD WAS IMPACTING ORGANS AND SOMETIMES IT HURT TO TURN THE INS ON. THE PATIENT WAS TAKING THINGS ONE STEP AT A TIME. THE PATIENT HAD CALCIUM DEPOSITS IN THEIR BACK WHERE THE DOCTOR GOES IN WITH A NEEDLE. "I NEED TO GET THAT DONE." THE PATIENT ALSO HAD A HERNIA, "DORMANT" CROHN'S DISEASE, 3 LARGE KIDNEY STONES ON THE RIGHT SIDE, AND A 7 CM (PARTIALLY CRYSTALIZED) CYST ON THEIR LEFT KIDNEY. IT WAS NOTED: "BUT FIRST THEY HAVE TO TAKE CARE OF THE HERNIA." THEN THE STONES. THEN A SAMPLE OF THE CYST. THEN THE CROHN'S DISEASE. THE PATIENT NOTED THAT THE HOSPITAL IN TOWN SAID SHE HAD A SMALL HEART ATTACK BECAUSE THEY SAW SCAR TISSUE. THEN THE DOCTORS "DID THE SAME PROCEDURE AND IT WAS GONE." THE PATIENT'S LEGS SWELL SO THEY TAKE LASIX. THE TRIAL "DID WHAT IT WAS SUPPOSED TO DO, BUT NOW THAT ITS IN THERE I CAN'T USE IT RIGHT NOW BECAUSE OF ALL THE OTHER THINGS GOING ON." IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417422 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR