BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESTORE ULTRA

    MDR report key: 3232552 · Received July 18, 2013

    Report

    Report Number
    3007566237-2013-02385
    Event Type
    Death
    Date Received
    July 18, 2013
    Date of Event
    May 29, 2013
    Report Date
    July 1, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CONCOMITANT PRODUCTS: PRODUCT ID: 39565, LOT# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT NO MALFUNCTIONS WERE OBSERVED AND DEVICES WERE NOT EXPLANTED.

    Description of Event or Problem · 1

    KIM, J., KIM, J. THE PRETTEY RARE SUDDEN DEATH AFTER IMPLANTATION OF SPINAL CORD STIMULATION. STEREOTACT FUNCT NEUROSURG 2013;91(SUPPL 1): 1-334 ¿ PAGE 277 SUMMARY: WE REPORT THE CASE THAT THE RARE SUDDEN DEATH OF UNKNOWN ORIGIN ASSOCIATED WITH SCS IMPLANTATION. BUT MOST REPORTS OVERLOOK THE COMPLICATIONS; THIS IS NOT CLEARLY IDENTIFIED AS YET. A 46-YEAR-OLD MAN PRESENTED WITH LOW BACK PAIN, RADIATING PAIN COMBINED WEAKNESS OWING TO SPINAL LIPOMATOSIS. HIS CURRENT DIAGNOSES WERE SPINAL LIPOMATOSIS, DM, PARTICULARLY FBSS (FAILED BACK SURGERY SYNDROME). WE SCHEDULED SCS IMPLANTATION, CHECKED SYMPTOM DURING 7 DAYS TESTING PERIODS, LOCATED T8-9 16 POLAR CHANNEL DEVICE. AFTER TESTING PERIODS, HIS SATISFACTION WAS VERY HIGH, DWINDLED AWAY VAS SCORE REACHED 3. 3 MONTHS LATER, SUDDEN ABNORMAL UNKNOWN SYMPTOMS STARTED DEVELOPING. WE COULDN'T FIND CAUSES SO TREATED WITH CONSERVATIVE METHODS. NOT INCREASING INFLAMMATORY LAB (CRP, ESR, WBC COUNTS), FEVER, WOULDN'T SEARCH THE PROBLEM. HIS VITAL SIGN WAS CHANGED TO NEARLY SEPTIC CONDITION, BUT NEUROLOGIC EXAM NORMAL STATE. WE DOUBTED THE CARDIAC PROBLEM, PERFORMED A CORONARY ANGIOGRAM, WAS NOT FOUND THE EVIDENCE OF PATIENT SITUATION. THE PATIENT'S BLOOD PRESSURE CONTINUOUSLY UNCHECKED TILL HE DIED FROM CARDIAC ARREST. OUR CASE WAS COMPLETELY DIFFERENT. ALTHOUGH LIFE-THREATENING COMPLICATIONS WITH SCS ARE VERY RARE, OTHER ADVERSE OCCURRENCES ARE FREQUENT. NOT FINDING THE CAUSE OF DEATH, BUT WOULD BE PRESUMED IN THE PRESENCE OF PROOF TO THE SCS PROCEDURE. THIS DIFFERENCE THAT ANALYZED THE INFECTION RATES WAS NOT STATISTICALLY SIGNIFICANT FORM THAT OF THE DIABETICS. WE REPORTED ABNORMAL SUDDEN DEATH COMPLICATION COULDN'T EXPLAIN THE CAUSES, BUT ESTIMATED CONCERNED WITH SCS IMPLANTATION. REPORTED EVENT: 46-YEAR-OLD MAN HAD VERY HIGH SATISFACTION AFTER TESTING PERIODS, BUT SATISFACTION DWINDLED AWAY VAS SCORE REACHED 3. 3 MONTHS LATER, SUDDEN ABNORMAL UNKNOWN SYMPTOMS STARTED DEVELOPING. THE CAUSE WAS UNKNOWN, SO PATIENT WAS TREATED WITH CONSERVATIVE METHODS. IT WAS NOTED THERE WAS FEVER AND NO INCREASING INFLAMMATORY LAB (CRP, ESR ,WBC COUNTS). THE PATIENT¿S VITAL SIGNS WERE CHANGED TO NEARLY SEPTIC CONDITION, BUT NEUROLOGIC EXAM FOUND THAT PATIENT WAS IN NORMAL STATE. CORONARY ANGIOGRAM WAS PERFORMED BUT DID NOT PROVIDE INFORMATION ON PATIENT SITUATION. THE PATIENT'S BLOOD PRESSURE CONTINUOUSLY UNCHECKED UNTIL HE DIED FROM CARDIAC ARREST. RARE SUDDEN DEATH OF UNKNOWN ORIGIN ASSOCIATED WITH SCS IMPLANTATION. NOT FINDING THE CAUSE OF DEATH, BUT WOULD BE PRESUMED IN THE PRESENCE OF PROOF TO THE SCS PROCEDURE. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333548 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 37712 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR Death