BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 8040501 · Received November 5, 2018

    Report

    Report Number
    3007566237-2018-03228
    Event Type
    Injury
    Date Received
    November 5, 2018
    Date of Event
    September 19, 2018
    Report Date
    November 5, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A USER FACILITY VIA A CONSUMER REGARDING A PATIENT RECEIVING MORPHINE WITH AN UNKNOWN DOSE AND CONCENTRATION AND CLONIDINE WITH AN UNKNOWN DOSE AND CONCENTRATION VIA AN IMPLANTABLE FOR NO KNOWN INDICATION FOR USE. IT WAS REPORTED THE PATIENT HAD A PAIN PUMP AND THIS WAS THEIR SECOND PUMP. IT WAS NOTED THE PATIENT HAD THEIR FIRST PUMP FOR 7 YEARS AND THE CURRENT PUMP FOR 1 1/2 YEARS. THE PATIENT REPORTED THEY DEVELOPED SEVERE/NEW/UNUSUAL BACK PAIN ABOUT 3:00AM AND THEN VOMITED FOR HOURS, WAS FREEZING/BURNING UP, HAD HIGH BLOOD PRESSURE, AND SEVERE JERKING OF THEIR LEGS. THE PATIENT STATED THERE WERE IN WITHDRAWAL FROM THE MORPHINE AND CLONIDINE IN THEIR PUMP. THEY PATIENT STATED THEY WERE UNFAIRLY NEGLECTED AT THE EMERGENCY ROOM (ER), EVEN THOUGH THEY INFORMED THEM THAT THEY HAD A PAIN PUMP AND HAD A HEART ATTACK. THE PATIENT STATED THEY WERE SCREENED AND THEN LEFT IN THE ER FOR 7 HOURS DRY HEAVING AND "MORE BLOOD PRESSURE." THE PATIENT NOTED THAT AT ONE POINT THERE BLOOD PRESSURE WAS 223/110. IT WAS NOTED THAT THE PATIENT WAS ADMITTED AND FINALLY GIVEN INTRAVENOUS (IV) MORPHINE. IT WAS NOTED THAT KIDNEY STONES AND URINARY TRACT INFECTION WERE RULED OUT. 24 HOURS LATER THE PATIENT WAS NO LONGER JERKING, THROWING UP, ETC. THE PATIENT'S PAIN SPECIALIST WAS AT A LOSS AS TO WHAT HAPPENED AS THE TESTING ON THEIR PUMP DID NOT SHOW THAT IT HAD STALLED, NOR DID IT EVER ALARM. THE PAIN SPECIALIST ALSO DID A "SIDE STUDY" TO CHECK THE FLOW OF THE CATHETER, AND IT WAS APPARENTLY FINE. THE ONLY OTHER SOLUTION WAS THAT THE PATIENT WILL HAVE THE RECENT PUMP MEDICATION EXTRACTED AND HAVE A NEW BATCH INJECTED "THIS THURSDAY" AND THE CONTENTS WILL BE ANALYZED. THE PATIENT STATED THEY JUST HAD THEIR PUMP REFILLED 2 1/2 WEEKS AGO. THE PATIENT STATED THEY WERE GIVEN A3 DAY FENTANYL PATCH TO HOLD THEM OVER THE WEEKEND UNTIL THEY GO INTO THEIR PAIN SPECIALIST, WHO THE PATIENT STATED DENIED KNOWING OF ANY RECALL ON THE PUMP." THE PATIENT STATED THEY WERE MOST LIKELY GOING TO GET A SECOND OPINION, SINCE THE PATIENT'S RESEARCH SHOWED THAT THIS PARTICULAR PUMP WAS INTACT RECALLED. THE PATIENT STATED THEY BECAME LETHARGIC AND SLEEPY, SO THE FENTANYL PATCH WAS REMOVED AND INFORMED THE PATIENT'S DOCTOR THAT THEIR PAIN SPECIALIST HAD NO IDEA "WHAT TO DO WITH ME." THE PATIENT NOTED THE PUMP SHOULD LAST 7 YEARS AND TO HAVE IT REPLACED WAS A SIGNIFICANT SURGERY, THE PATIENT NOTED THE PUMP HAD NOT BEEN REMOVED OR REPLACED YET. CONCOMITANT MEDICAL PRODUCTS INCLUDED MORPHINE/CLONIDINE, ASPIRIN 81MG, PLAVIX 75MG, ZOCOR, ATENOLOL 2X DAILY, NITROGLYCERIN (ON STANDBY), CONCERTA, VALTREX (PROPHYLACTIC), DHEA, SENAKOT, COQ10, TYLENOL ARTHRITIS, AND GAS-X. THE EVENT DATE WAS (B)(6) 2018. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876999 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R