BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 3970363 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-13740
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Report Date
    July 28, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD; PRODUCT ID 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD; PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD; PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A ¿KNOT¿ IN HIS BACK THAT WAS THERE WHEN STIMULATION WAS TURNED ON (B)(6). IT WAS STATED THAT THE PATIENT¿S HEALTHCARE PROFESSIONAL (HCP) TOLD HIM AT THAT TIME THAT IT MAY HAVE NEEDED TO BE DRAINED BUT THAT IT WOULD GO AWAY. IT WAS REPORTED THAT TWO DAYS LATER ((B)(6)), THE PATIENT WAS IN A CAR ACCIDENT. IT WAS REPORTED THAT FOLLOWING THE ACCIDENT THE HCP HAD THE KNOT DRAINED BUT IT WAS REPORTED THAT KNOT WAS STILL PRESENT. IT WAS STATED THAT THE HCP TOLD THE PATIENT THE KNOT WOULD ¿NEVER GO AWAY¿ AND THAT IT WAS ¿TO GIVE THE PATIENT FLEXIBILITY¿. IT WAS REPORTED THAT THE HCP DID X-RAYS AND SAID THE LEADS WERE ¿OK¿. LATER ON (B)(6) 2014 THE PATIENT REPORTED THAT HE WAS AT A NURSING FACILITY DUE TO FALLING OFF A HORSE ¿PRETTY HARD LAST TUESDAY¿ AND WAS ¿HAVING PROBLEMS.¿ THE PATIENT STATED HE FELT BURNING AND NOTED ¿THE KNOT ON THE BACK THAT WAS NORMALLY THERE WAS NO LONGER THERE.¿ THE PATIENT STATED THAT THE KNOT WAS THE EXCESS SLACK IN THE LEAD. THE PATIENT ALSO STATED THAT THE BURNING WAS FELT ON THE LEFT HIP BUT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS ON THE RIGHT HIP. THE PATIENT STATED THAT WHEN HE TURNED THE INS OFF ¿IT FELT LIKE HE WAS BURNT INSIDE.¿ THE PATIENT WAS DIRECTED TO THE DOCTOR TO CHECK THE INTEGRITY OF THE SYSTEM. THE PATIENT MENTIONED THAT DUE TO THE FALL HE HAD TAKEN AN AMBULANCE TO THE EMERGENCY ROOM (ER) AND THE FIRST DOCTOR THOUGHT THE PATIENT DID NOT BREAK ANYTHING. THE PATIENT STATED THAT A CT SCAN SHOWED THAT HE FRACTURED HIS TRANSVERSE PROCESS ON THE LEFT SIDE. THE CALLER STATED THAT HE WAS IN EXCRUCIATING PAIN ON THE ¿LOWER PART.¿ THE PATIENT ALSO NOTED IN (B)(6) HE FRACTURED HIS RIGHT SIDE TRANSVERSE PROCESS.¿ THE PATIENT STATED THAT HE WENT TO TYLER AND THEY DID AN MRI AND HE ALSO FRACTURED T12 AND STILL HAD ¿LOTS OF TROUBLE.¿ IT WAS NOTED THAT THE PATIENT STILL HAD ¿LOTS OF PAIN AND HE COULD NOT STAND IT.¿ THE PATIENT STATED THEN ¿THEY¿ SAW A BROKEN RIB ON THE ABDOMEN CT SCAN AND THE DOCTOR WAS NOT SURE WHICH RIB. THE PATIENT ALSO STATED HE ¿COUGHED UP BLOOD OUT OF HIS LUNGS A FEW DAYS AGO.¿ THE PATIENT REITERATED THAT HE WAS THROWN FAR OFF OF THE HORSE. THE PATIENT WAS FRUSTRATED THAT ¿EVERYONE WAS TELLING HIM SOMETHING DIFFERENT.¿ THE PATIENT STATED THAT THE ER DOCTORS ¿DID NOT HAVE THE RIGHT DIAGNOSIS YET.¿ THE PATIENT THOUGHT IT WAS DUE TO ¿EVERY DOCTOR GIVING HIM A DIFFERENT STORY.¿ THE PATIENT STATED THAT HE TURNED THE DEVICE OFF ONE DAY PRIOR TO (B)(6) 2014 AND HE GOT UP AND WAS ABLE TO WALK. THE PATIENT ALSO STATED THAT SINCE TURNING THE INS OFF ¿HE COULD DEAL WITH THE PAIN.¿ ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT EXPERIENCED A SEROMA. THE OUTCOME WAS RESOLVED WITHOUT SEQUELAE ON (B)(6) 2014. INTERVENTIONS INCLUDED MEDICAL OR NON-SURGICAL THERAPY INCLUDING ASPIRATING 6 CC OF SEROSANGUINEOUS FLUID FROM LUMBAR SEROMA. DIAGNOSTIC METHODS INCLUDED EXAMINATION AND PALPATION. THE PATIENT WAS INVOLVED IN A MOTOR VEHICLE ACCIDENT AND THEN BEGAN TO HAVE SWELLING AT HIS LUMBAR DEVICE SITE. X-RAYS WERE TAKEN AND THE SPINAL CORD STIMULATOR (SCS) LEADS WERE IN THE PROPER POSITION. THE SEROMA FLUID WAS NEGATIVE FOR INFECTION. THE DEVICE WAS INTERROGATED AND IMPEDANCES WERE WITHIN NORMAL LIMITS. THE DEVICE WAS FUNCTIONING APPROPRIATELY. THE PATIENT EXPERIENCED A SLIGHT SWELLING AND TENDERNESS TO THE LUMBAR DEVICE SITE. EXAMINATION AND PALPATION SHOWED ¿BUBBLE¿ ALONG MID SPINE AT THE LEAD SITE AND WAS NEGATIVE FOR SIGNS OF INFECTION. LATER IT WAS REPORTED THAT THE RESULTS WERE WELL HEALED. THE EVENT WAS POSSIBLY RELATED TO THE DEVICE OR THERAPY AND POSSIBLY RELATED TO THE IMPLANT PROCEDURE. THE SEVERITY WAS REPORTED AS MILD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447655 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714

    Patients

    Seq Age Sex Outcome Treatment
    1