BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3604692 · Received February 3, 2014

    Report

    Report Number
    3004209178-2014-01528
    Event Type
    Injury
    Date Received
    February 3, 2014
    Report Date
    January 16, 2014
    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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP FOUND NO SIGNIFICANT ANOMALY; O-RING WEAR OF THE MOTOR WAS SEEN. ANALYSIS TESTING SHOWED THE PUMP WAS DISPENSING ACCURATELY.

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THERE WAS NO PATIENT INJURY. PRIOR TO DEVICE REMOVAL, NO ROTOR OR DYE STUDIES WERE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN OVERDOSE OCCURRED AND THE PATIENT¿S THERAPY WASN¿T WORKING AS EXPECTED. THE PATIENT WAS IN THE HOSPITAL THE DAY PRIOR TO THE REPORT DATE FOLLOWING A REFILL. IT WAS REPORTED THIS WAS THE THIRD TIME THIS HAD HAPPENED. THE PATIENT¿S HEALTH CARE PROVIDER (HCP) WAS REPORTEDLY OVERDOSING HIM SO HE COULD HAVE THE PATIENT COME IN SOONER FOR REFILLS. THE PATIENT WENT TO THE HOSPITAL AND WAS GIVEN NARCAN BECAUSE THE PUMP WAS ¿MALFUNCTIONING¿ AND KICKING OUT TOO MUCH FENTANYL. IT WAS REPORTED ¿I ALMOST DIED TODAY, I GOT SO SICK AND I WAS THERE FOR A DAY AND A HAL,F THEY WANTED TO KEEP ME FOR THREE DAYS.¿ IT WAS THEN REPORTED THE HCP HAD SAID ¿NO YOU JUST HAD THE FLU AND HE¿S BUYING ME SWEATERS AND JACKETS AND GIVING ME MONEY AND [PROFANITY].¿ THE HCP WAS REPORTEDLY TRYING TO COVER UP THAT THE PUMP WAS MALFUNCTIONING ¿OR THEY FILLED IT WRONG.¿ THE PATIENT HAD GONE TO THE EMERGENCY ROOM AND THEY TESTED HIS BLOOD FOR FENTANYL AND THERE WAS ¿LOTS¿ OF FENTANYL IN THE PATIENT¿S BODY. THE HCP REPORTEDLY SAID ¿NO NOTHING IS WRONG WITH THE PUMP.¿ THE PATIENT¿S HCP WAS NICE AND THE PATIENT¿S BEST FRIEND BUT HE DIDN¿T TRUST HIM. IT WAS REPORTED THAT EVERY TIME THE PATIENT GOT A REFILL, TWENTY MINUTES LATER, HE PASSES OUT AND HAS TO GO TO THE HOSPITAL TO GET NARCAN. THE PATIENT WOULD SEE WHEN THE NEEDLE IS TAKEN OUT AND HE DIDN¿T SEE ANY MEDICATION LEAK OUT. THE PATIENT HOWEVER WOULD PASS OUT AND AN AMBULANCE WOULD HAVE TO COME GET HIM BECAUSE HE CAN¿T WAKE UP. THE HCP REPORTEDLY DIDN¿T WANT THE PATIENT TO GET RID OF THE PUMP. THE PATIENT HOWEVER WOULD LIKE IT REMOVED AND WAS AFRAID THE HCP WOULD DISMISS HIM AND HE WOULD DIE.¿ IT WAS NOTED THE PATIENT¿S DOSING WAS SO HIGH THAT HE COULDN¿T LEGALLY GET HIS PUMP FILLED. THE PATIENT WAS ON 25 MILLIGRAMS OF FENTANYL HOWEVER IN (B)(6) IT WAS ONLY CONTRAINDICATED FOR 4MG. THE HCP HAD REPORTEDLY TRIED TO TITRATE THE PUMP AND THE PATIENT WAS AS A RESULT IN ¿LOTS¿ OF PAIN AND HE ¿CAN¿T EVEN MOVE.¿ THE PATIENT AS REPORTED WANTED TO GET HIS PUMP REMOVED AND WANTED TO KNOW IF HE COULD GET ORAL MEDICATION TO COVER THE PAIN OR IF HE WOULD DIE OF PAIN. THE DEVICE SYSTEM WAS USED TO DELIVER FENTANYL AT A DOSE OF 8.263MG, CLONIDINE AT A DOSE OF .9915MG AND MARCAINE AT A DOSE OF 1.6525MG. IT WAS LATER REPORTED THAT A CHANGE IN THERAPY EFFECT OCCURRED. PATIENT SYMPTOMS INCLUDED BEING LIGHT HEADED AND PASSING OUT DURING ¿NORMAL REFILL CYCLE¿ AND FOLLOWING A REFILL SESSION. THE PUMP WAS REPLACED. FENTANYL HAD BEEN THE DRIVING DRUG IN THE PUMP. SPECIFIC CONCENTRATIONS AND DOSES WERE UNKNOWN TO THE DEVICE MANUFACTURER REPRESENTATIVE AT THE TIME OF THE REPORT. HOWEVER, THE REPORTER THOUGHT THE PATIENT WAS ON A HIGH DOSE OF FENTANYL. THE PATIENT HAD REPORTED A HISTORY OF FEELING LIGHTHEADED AND PASSING OUT FOLLOWING REFILLS. THE SYMPTOMS WOULD REPORTEDLY RESOLVE AND IT WAS REPORTED ¿NO INTERVENTION WERE REQUIRED INCLUDING DOSE REDUCTION, NARCAN ETC.¿ THE PATIENT BELIEVED THERE WAS SOMETHING WRONG WITH THE REFILL SEPTUM, ¿POSSIBLY LEAKING.¿ THE HCP DIDN¿T WANT TO TAKE ANY CHANCES AND REPLACED THE PUMP. THE PUMP WAS TO BE RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70030 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R