BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 4840601 · Received June 12, 2015

    Report

    Report Number
    3004209178-2015-11522
    Event Type
    Malfunction
    Date Received
    June 12, 2015
    Report Date
    June 4, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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

    CONCOMITANT PRODUCTS: PRODUCT ID: 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON JUNE 15TH 2015 INDICATING THAT THE PATIENT WAS SCHEDULED FOR AN MRI ON (B)(6) 2015 TO CHECK FOR A BLOWN DISK IN THEIR BACK AND CHECK LEAD WIRE POSITIONING TO SEE IF ANY LEADS WERE OUT OF PLACE. THE PATIENT HAD PAIN WHICH HAD BEEN GOING ON SINCE (B)(6) 2015 BUT ON (B)(6) 2015, THEY STEPPED OUT OF THE SHOWER AND FELT EXCRUCIATING PAIN THAT LASTED FOR A FEW SECONDS. ON (B)(6) 2015 THEY STEPPED OUT OF THE SHOWER AND FELT THE SAME PAIN FOR 5 MINUTES, THE PATIENT HAD RECEIVED TWO INJECTIONS FOR THE PAIN THAT HAD NOT HELPED A , ¿METRO PACK¿ FOR PAIN DID NOT HELP AND THE PCP GAVE HIM A ¿A TRIGGER POINT¿ INJECTION IN THE PAIN SITE AND THAT DID HELP THE PAIN. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IN EXCRUCIATING PAIN AND IT STARTED A WEEK AGO. IT HAD BEEN GETTING PROGRESSIVELY WORSE AND TODAY IT HAD ¿STOPPED ME IN MY TRACKS.¿ HE WAS CONCERNED THAT ¿MAYBE A LEAD WENT BAD OR SOMETHING.¿ THIS WAS CONCERNING TO A MANUFACTURING REPRESENTATIVE (REP) AND THEY WERE GOING TO REACH OUT TO THE PATIENT TO SUGGEST CALLING THEIR HEALTHCARE PROVIDER (HCP) OFFICE OR REPORT TO AN EMERGENCY ROOM (ER). EXCRUCIATING PAIN GETTING WORSE COULD INDICATE A VERY SERIOUS ISSUE REQUIRING IMMEDIATE ATTENTION. IT WAS LATER REPORTED THAT THE PATIENT RECEIVED ¿TWO SHOTS AND A ZPAK¿ FROM HIS PRIMARY CARE PHYSICIAN (PCP). THE REP WAS NOT SURE WHAT THE SHOTS WERE OR WHAT THE INFECTIOUS PROCESS WAS HE RECEIVED A ZPAK FOR. THE PATIENT WAS FEELING BETTER SINCE SEEING HIS PCP AND DID NOT NEED TO SEE THE REP RELATED TO HIS STIMULATOR. IT WAS LATER DETERMINED THAT THE ZPAK WAS NOT FOR AN INFECTION BUT FOR SWELLING HE HAD IN HIS BACK. THE PAIN WAS THE SAME PAIN THEY HAD BEFORE EXCEPT IT WAS NOT SHOOTING DOWN THE BACK OF HIS LEG; IT WAS STAYING IN HIS LOWER RIGHT BACK. THE PATIENT DID NOT KNOW WHAT EXACTLY CAUSED THE SWELLING BUT HE DID FEEL PAIN IN HIS BACK IMMEDIATELY AFTER STEPPING OUT OF HIS TUB A COUPLE DIFFERENT TIMES. HE TRIED INCREASING HIS STIMULATION BUT IT DID NOT HELP THE PAIN. THE PATIENT HAD BEEN HAVING BACK PAIN BEFORE HIS DEVICE WAS IMPLANTED. HE HAD SURGERY IN (B)(6) AND THEN 4-5 YEARS AFTER THAT HE HAD TO START GETTING CORTISONE SHOTS IN HIS SPINE FOR HIS BACK PAIN FOR A FEW YEARS. THEN ABOUT A YEAR AND A HALF AFTER THAT HE HAD A NERVE CAUTERIZED TO TRY AND TREAT THE PAIN. BUT THE PAIN RETURNED AND THEN THE PATIENT GOT HIS SPINAL CORD STIMULATOR (SCS) DEVICE IMPLANTED TO SEE IF THAT WOULD HELP THE PAIN. HE ALSO WORE A BACK BRACE, WHICH SOMETIMES HELPED AND SOMETIME AGGRAVATED THEM. ON (B)(6) 2015, THE PATIENT WENT TO HIS PCP AND HAD TRIGGER POINT INJECTIONS TO HELP HIS PAIN. THE INJECTIONS SEEMED TO WORK BUT THEY ONLY LASTED FOR ABOUT 4 HOURS. THEY WERE THINKING OR WANTED TO RULE OUT ANY ISSUES WITH THE LEADS. THEY CALLED ANOTHER HCP OFFICE REQUESTING TO RECEIVE SPINAL SHOTS AND TO HAVE THE DEVICE CHECKED TO MAKE SURE IT WAS WORKING PROPERLY. THE PATIENT HAD AN MRI SCHEDULED FOR (B)(6) FOR THE LOWER BACK. THE DIAGNOSIS WAS MUSCLE SPASMS AND POSSIBLE RUPTURED DISC. THE MRI WAS TO CONFIRM AND LOOK FOR A RUPTURED DISC. IT WAS NOTED THAT THE RUPTURED DISC WAS NOT RELATED TO THEIR DEVICE OR THERAPY. HE HAD RUPTURED/BULGING DISCS BEFORE HE GOT THE DEVICE IMPLANTED. 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
    386529 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97702

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR