BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3811385 · Received May 15, 2014

    Report

    Report Number
    3004209178-2014-09000
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    April 1, 2013
    Report Date
    July 6, 2017
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: CATHETER.

    Additional Manufacturer Narrative · 1

    UPDATED TO REFLECT THE PATIENT'S WEIGHT AT THE TIME OF THE EVENT RECEIVED ON (B)(6) 2017. UPDATED TO REFLECT THE INFORMATION RECEIVED ON (B)(6) 2017.

    Additional Manufacturer Narrative · 1

    OTHER COMPONENTS INCLUDE: PRODUCT ID (B)(4) LOT# SERIAL# (B)(4) IMPLANTED: (B)(6) 2010 EXPLANTED: PRODUCT TYPE CATHETER PRODUCT ID (B)(4) LOT# SERIAL# (B)(4) IMPLANTED: (B)(6) 2010 EXPLANTED: PRODUCT TYPE CATHETER: UPDATED TO REFLECT THE INFORMATION RECEIVED ON 2017-JUN-06 SECTION E: UPDATED TO REFLECT THE FACILITY ASSOCIATED WITH THIS EVENT AS REPORTED ON (B)(6) 2017: CONCLUSION CODE(B)(4) REMOVED AS THIS CONCLUSION CODE IS NO LONGER USED. DEVICE CODE (B)(4) ADDED TO REFLECT THE INFORMATION REGARDING THE ALLEGED MOTOR STALLS OCCURRING WHEN THE PATIENT WENT THROUGH AIRPORT SECURITY SCREENERS. PATIENT CODE (B)(6) WAS CODED TO REFLECT THAT NO SYMPTOMS WERE DIRECTLY ASSOCIATED WITH THE ISSUE OF THE PATIENT'S CATHETER. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT WAS TRAVELING DURING THE PREVIOUSLY REPORTED EVENT. HER PAIN WAS MUCH WORSE WHILE IN AN ELEVATED AREA. NO MOTOR STALLS OR VOLUME DISCREPANCIES OCCURRED. AT THE TIME OF THIS REPORT, THE PATIENT WAS DOING WELL AND NO FURTHER PROBLEMS OCCURRED. AT THE TIME OF THIS REPORT, THE DEVICE SYSTEM WAS USED TO DELIVER SUFENTA, CLONIDINE AND BUPIVACAINE. NO FURTHER DETAILS REGARDING THE PREVIOUSLY REPORTED DEVICE ISSUES WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER ON (B)(6) 2017. IT WAS REPORTED THAT THE PATIENT REPORTED THE CATHETER ISSUE THAT FELT LIKE "PANIC ATTACKS" IN (B)(6) 2015 WHEN THEY FLEW TO (B)(6). THE PATIENT'S WEIGHT WAS ALSO REPORTED. THE PATIENT FEELING SICK WHILE DRIVING DURING THEIR TRIP TO (B)(6) IN (B)(6) 2015 WAS NOT REPORTED TO THE CLINIC. NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT ON 2017-JUN-06. THE PATIENT REPORTED THAT THEY FELT THAT SOMETHING WAS WRONG WITH THE CATHETER. THEY WERE UNSURE ABOUT THE CAUSE FOR THE ISSUE OR WHEN IT BEGAN, BUT NOTED THAT IT OCCURRED WHEN THE PATIENT WAS FLYING. THE PATIENT STATED THAT OTHERS INDICATED THAT THE PATIENT WAS HAVING ANXIETY ATTACKS, BUT THE PATIENT KNEW THAT THIS WAS UNTRUE AS THEY HAD BEEN TESTED BY A PSYCHIATRIST. THE PATIENT ALSO REPORTED THAT THEY FELT SICK WHEN DRIVING WHEN THEY VISITED THE (B)(6) IN 2015. THE PATIENT ALSO REPORTED THAT FOR, THE LAST 10 TO 12 YEARS WHEN THEY FLY, THE AIRPORT SECURITY GATES SHUT OFF THE PUMP. THE PUMP WOULD RECOVER RIGHT AWAY, BUT THE PATIENT WOULD EXPERIENCE WITHDRAWAL DURING THE TIME PRIOR TO THE PUMP RECOVERY. THE PATIENT STATED THAT THEY HAVE NOT FLOWN SINCE (B)(6) FOR THIS ISSUE. NO FURTHER COMPLICATIONS WERE REPORTED. .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S PUMP ¿WENT OFF¿ AT THE AIRPORT. IT WAS NOTED THAT AFTER THE PATIENT GOT TO THEIR DESTINATION, THEY HAD A BAD REACTION LIKE THEY ¿HADN¿T BEEN GETTING MEDICATION. IT WAS FURTHER STATED THAT ¿IT WAS LIKE THE PUMP RESET ITSELF¿ AND THE PATIENT STARTED FEELING BETTER. IT WAS NOTED THAT IT FELT LIKE A ¿WITHDRAWAL.¿ IT WAS NOTED THAT IT HAPPENED ON (B)(6) 2014 AND IN (B)(6) 2013. IT WAS NOTED THAT THE PATIENT DID NOT HEAR ANY PUMP ALARMS. AFTER PATIENT SERVICES EXPLAINED TO PATIENT THAT HIGH ALTITUDE COULD CAUSE THE FLOW RATE TO INCREASE, THE PATIENT REPORTED THAT THEY WENT TO THE GRAND CANNON ON (B)(6) 2014 AND WAS SO SICK. IT WAS ALSO REPORTED THAT THE PATIENT FELT LIKE THEY WERE GETTING TOO MUCH MEDICATION. IT WAS NOTED THAT THE SYMPTOMS FELT ON (B)(6) 2014 AND (B)(6) OF 2013 WERE SO INTENSE, ¿ACHING AND HURTING ALL OVER,¿ FELT LIKE THEY WERE GOING TO JUMP OUT OF THEIR SKIN. IT WAS NOTED THAT THE PATIENT COULD TASTE AND SMELL THE MEDICINE. IT WAS NOTED THAT AT SOME POINTS T HEY WERE UP TO 8000 FEET. IT WAS FURTHER STATED THAT THE PATIENT HAD NEVER HAD A WITHDRAWAL. THE PUMP SYSTEM WAS DELIVERING CLONIDINE, FENTANYL AND BUPIVACAINE AT THE TIME OF REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290482 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Other