BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED II

    MDR report key: 2490117 · Received March 13, 2012

    Report

    Report Number
    3007566237-2012-00531
    Event Type
    Death
    Date Received
    March 13, 2012
    Report Date
    September 5, 2017
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: CATHETER MODEL# 8709SC SERIAL# (B)(4) IMPLANTED: (B)(6) 2007 EXPLANTED: UNK.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCED THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: CATHETER. PRODUCT ID: 8840, PRODUCT TYPE: PROGRAMMER, PHYSICIAN. CONCLUSION CODE UPDATED.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE HCP REPORTED THE PATIENT DIED. THE CAUSE OF THE PATIENT'S DEATH WAS UNKNOWN. THE PATIENT DIED 5 HOURS AFTER A REFILL PROCEDURE IN WHICH A CONCENTRATION CHANGE AND DOSE CHANGE WAS PROGRAMMED. THE HCP DID NOT PERFORM A BRIDGE BOLUS, HOWEVER, THE NEW CONCENTRATION DID NOT REACH THE PATIENT AT THE TIME OF DEATH. THE PUMP WAS RUNNING AT 10MG/ML, 4.2MG/DAY (20% INCREASE) AT THE TIME OF THE DEATH. PRIOR TO THE REFILL, THE DOSE WAS AT 3.505 MG/DAY. THE PUMP WAS RUNNING AT .0175ML/HOUR AND THE TUBING AND CATHETER VOLUME WAS .369ML. THE PUMP WAS DELIVERING HYDROMORPHONE. PER THE MEDICAL EXAMINER'S OFFICE, THE CAUSE OF DEATH COULD NOT BE DETERMINED AT THIS TIME. THEY HAD SENT BLOOD SAMPLE TO TOXICOLOGY AND HAD TO WAIT ON THOSE RESULTS TO MAKE DETERMINATION OF CAUSE OR DECIDE NEXT STEP. AT THE TIME OF THIS REPORT, THEY WERE NOT DOING ANYTHING WITH THE PUMP; IT WAS REMOVED FROM THE PATIENT AND WAS SEALED UP. PER THE HCP, THE MEDICAL EXAMINER HAD CALLED FOR MORE DETAILS. THE HCP ASKED THE ME IF FLUID WAS TAKEN OUT AND THEY SAID IT WAS NOT. SHE DOESN'T KNOW IF THE MEDICATION WILL BE TESTED. SHE ASKED ABOUT THE CATHETER, THEY SAID IT LOOKED NORMAL. TELEMETRY STRIPS WERE SENT TO ME. THE HCP PULLED THE SYRINGE USED FOR THIS PATIENT AND BAGGED IT, JUST IN CASE IT WOULD BE HELPFUL FOR FURTHER STUDY, BUT THERE WAS NOT MUCH LIQUID IN IT THE PATIENT'S CHART HAD ALSO BEEN COPIED. THE HCP HAD ONLY SEEN THE PATIENT ONCE PRIOR TO THIS VISIT AS HIS PERMANENT RESIDENCE WAS IN ANOTHER STATE AND HE WAS ONLY WINTERING IN (B)(6).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: THE MEDICAL EXAMINER REPORTED THAT THE CAUSE OF DEATH WAS NATURAL CAUSES; ACUTE CARDIAC ATTACK DUE TO CORONARY ARTERY DISEASE. IT WAS NOTED THAT THEY WOULD NOT BE TESTING MEDICATION IN THE PUMP. TOXICOLOGY RESULTS SHOWED: "CANOIDE", OPIATES, STIMULANTS (CAFFEINE, "COTTONENE"), HYDROMOPHONE, OXYCODONE AND THC.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2017 FROM A HEALTHCARE PROFESSIONAL (HCP) WHO WAS REQUESTING INFORMATION ON HOW THE PUMP FUNCTIONS. PER THE REPORTER, THE HCP WHO PERFORMED THE REFILL PRIOR TO THE PATIENT¿S DEATH FILLED THE PUMP WITH 30 MG/ML OF DILAUDID BUT PROGRAMMED THE DRUG INFORMATION AS 10 MG/ML WHICH WAS THE SAME AS WHAT WAS ORIGINALLY IN THE PUMP PRIOR TO THE REFILL. THE HCP THEN INCREASED THE DOSE FROM 3.2 MG/DAY TO 4.2 MG/DAY AND DID NOT PERFORM A BRIDGE BOLUS. THE REPORTER STILL HAD THE PUMP WITH THE DRUG INSIDE AND WAS WANTING TO KNOW IF THEY COULD STILL PULL OUT THE DRUG IN THE PUMP AND MEASURE ITS TRUE CONCENTRATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP). THE PATIENT'S WEIGHT WAS (B)(6). THE SERIAL NUMBER OF THE CLINICIAN PROGRAMMER WAS UNKNOWN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) ON (B)(6) 2017. THE HCP INQUIRED HOW TO DETERMINE IF THERE WAS ANY DRUG LEFT IN THE PUMP RESERVOIR TO BE ABLE TO TEST THE DRUG. THE PUMP HAD BEEN IN STORAGE FOR OVER FIVE YEARS SINCE THE PATIENT DIED. PER THE TELEMETRY STRIPS, THE PUMP WAS LAST EXAMINED AT (B)(6) 2012 WAS THE LAST CHANGE. THE DRUG WAS HYDROMORPHONE 10 MG/ML AT 3.505 MG/DAY FOR THE OLD SETTING AND ON (B)(6) 2012, THE PUMP WAS UPDATED TO HYDROMORPHONE 10 MG/ML AT 4.200 MG/DAY. THE PHARMACY HAD CHANGED THE CONCENTRATION TO 30 MG/ML WITH NO BRIDGE BOLUS OR CONCENTRATION CHANGES MADE WITH THE PROGRAMMING. THE PATIENT DIED SHORTLY AFTER THAT PER THE HCP.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP). IT WAS REPORTED THAT IT WAS ALLEGED THAT THE MEDICATION CAN TRAVERSE THE CATHETER ON TOP OF THE CURRENT MEDICATION THAT WAS IN THERE. IT WAS CLAIMED THAT THE NEW MEDICATION IN THE RESERVOIR TRAVELED OVER THE CURRENT MEDICATION AND DELIVERED TO THE PATIENT BEFORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death