BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 3201130 · Received July 2, 2013

    Report

    Report Number
    6000032-2013-00160
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    December 7, 2018
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 7495LZ, SERIAL# (B)(4), IMPLANTED: (B)(6) 2001, PRODUCT TYPE EXTENSION; PRODUCT ID 3487A-56, LOT# J0120672V, IMPLANTED: (B)(6) 2001, PRODUCT TYPE LEAD; PRODUCT ID 3550-09, LOT# LB2875, IMPLANTED: (B)(6) 2004, PRODUCT TYPE ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A BURNING SENSATION. IT WAS STATED "IT WAS INFLAMED, HIS SPINE WAS ON FIRE." IT WAS STATED THAT THE PATIENT WANTED HIS DEVICE REMOVED BUT DIDN'T KNOW HOW TO DO IT. IT WAS STATED "IT WAS SLOWLY FILLING THE PATIENT: SORE FROM BACK AND NECK AND IT WAS AFFECTING HIS BRAIN AND THE WAY HE THOUGHT." IT WAS STATED THAT THE SOONER THE DEVICE WOULD BE OUT, THE BETTER HE WOULD BE FEELING. IT WAS REPORTED THAT THE INFLAMMATION WAS AT THE LEAD LOCATION. IT WAS STATED THAT IT HAD BEEN INFLAMED FOR A MONTH BEFORE THE REPORT BUT THEN IT WAS ALSO CLARIFIED THAT IT HAD BEEN BURNING AND INFLAMED FOR 2-3 YEARS WITH STEADILY GETTING WORSE. IT WAS ALSO COMMENTED THAT HE WAS VERY ACTIVE, STRONG ATHLETE AND UNDERSTOOD THAT THE WIRES WERE AFFECTED BY HIS ACTIVITY. IT WAS STATED THAT HE INITIALLY HAD RECEIVED THE IMPLANT DUE TO PAIN IN STERNUM AFTER A TRIPLE BYPASS SURGERY BUT AT THE TIME OF THE REPORT BASED ON HIS EXERCISE AND TRAINING "HE BELIEVED HE HAD BUILT THAT BACK UP AND DIDN'T NEED THE IMPLANT ANYMORE." IT WAS COMMENTED THAT THE STIMULATOR HAD DEPLETED SEVERAL YEARS PRIOR TO THE REPORT BUT IT HAD HELPED WITH HIS PAIN. IT WAS ALSO STATED THAT THE PATIENT WOULD HAVE AN APPOINTMENT ONE WEEK LATER AND WOULD WORK WITH HIS NEUROSURGEON TO HAVE THE DEVICE REMOVED. IT WAS ALSO REPORTED THAT "THE WI-FI SYSTEM AND ELECTRICITY FLOATING AROUND IN THE AREA AND WHEN HE HAD WIRES INSIDE HIS BODY, THEY WERE ACTIVE ANTENNAS AND THEY PICKED UP THE ELECTRICITY AND THEY BURNED THE WIRES." IT WAS STATED THAT THE PATIENT "HAD BEEN TOLD TO STAY AWAY FROM MICROWAVES, AND KNEW IT WAS RF (RADIO-FREQUENCY), WAS BURNED SEVERAL TIMES BY RADAR SYSTEMS WHILE IN MILITARY." IT WAS STATED THAT THE WIRES WERE PICKING UP THE WI-FI. IT WAS ALSO STATED THAT BIG SCREEN TVS RADIATED ENERGY AND THAT HE COULD SENSE THE ENERGY. IT WAS STATED THAT "IT HAD GOT TO BE THE WI-FI AS WI-FI HAD GOTTEN REALLY STRONG OVER THE YEARS." IT WAS REPORTED THAT THE DEVICE HAD BEEN DOING A GOOD JOB, BUT "THE PATIENT DID NOT WANT MORE SURGERIES AS HE HAD ALREADY BEEN CUT OUT 8-9 TIMES IN PAST." IT WAS STATED THAT THE PATIENT THOUGHT "HE WAS ALLERGIC TO IT, TOO SENSITIVE." IT WAS STATED THAT THE PATIENT ALSO EXERCISED A LOT AND DIDN'T BELIEVE THAT IT WAS GOOD FOR THE WIRES. IT WAS STATED THAT THE CHEST WAS STRONG ENOUGH, AND THAT THE PATIENT HAD STRENGTHENED IT UP. PATIENT'S BACK WAS BURNING UP BACK TOO MUCH. IT WAS ALSO NOTED THAT THE PATIENT ALSO LIVED UNDER HIGH TENSION WIRES ABOUT 500 YARDS FROM HIM. TWO AND A HALF WEEKS LATER IT WAS REPORTED THAT THE PATIENT DID NOT HAVE CONCERNS WITH HIS DEVICE, "JUST EMI."

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS REPORTED THAT THE PATIENT HAD A MAJOR PROBLEM, AND WANTS TO TALK TO WITH SOMEONE WHO IS MORE TECHNICALLY ADVANCED. THE PATIENT WANTS TO TALK TO SOMEONE ABOUT INDUCTION OF ELECTRICITY THROUGH THE CABLE. WHEN THE AGENT WENT TO FIND ANOTHER AGENT THE PATIENT DISCONNECTED THE CALL. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303230 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT SOFAMOR DANEK PUERTO RICO MFG 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR