BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 8628330 · Received May 21, 2019

    Report

    Report Number
    3004209178-2019-09978
    Event Type
    Injury
    Date Received
    May 21, 2019
    Date of Event
    May 3, 2019
    Report Date
    May 21, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00643169630505
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709SC, SERIAL #: (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: CATHETER. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 8709SC, SERIAL/LOT #: (B)(4), UBD: 14-MAY-2014, UDI #: (B)(4). PATIENT CODE (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER ON 2019-MAY-17 REGARDING A PATIENT RECEIVING FENTANYL (406.6MCG/DAY), BUPIVACAINE (2.033MG/DAY), AND DILAUDID (4.066MG/DAY) ALL AT UNKNOWN CONCENTRATIONS VIA AN IMPLANTED INFUSION PUMP. THE INDICATION FOR USE WAS SPINAL PAIN. IT WAS REPORTED THAT THE PATIENT HAD BEEN EXPERIENCING WITHDRAWAL SYMPTOMS FOR THE LAST TWO WEEKS STARTING ON (B)(6) 2019. THE PATIENT HAD DIARRHEA FOR 11 DAYS AND HOT/COLD PANIC ATTACKS, VOMITING, AND LOSS OF APPETITE. AS A RESULT THE PATIENT LOST 20 LBS. AND LOSS OF PAIN MANAGEMENT. ON (B)(6) 2019 THE PATIENT CALLED A NURSE AT THE HEALTHCARE PROVIDER'S (HCP) OFFICE AND WAS DIRECTED TO THE EMERGENCY ROOM (ER). THE PATIENT WENT TO THE ER AS DIRECTED HOWEVER INSTEAD OF CONTACTING THE ON-CALL PHYSICIAN THE ER STAFF PERFORMED BLOOD WORK AND PERFORMED A COMPUTERIZED TOMOGRAPHY (CT) SCAN AND TOLD THEM THE BLOOD WORK CAME OUT FINE. THEY WERE TOLD IT SOUNDED LIKE A STOMACH VIRUS, AND THE PATIENT WAS GIVEN DILAUDID, INTRAVENOUS (IV) ATIVAN, AND ZOFRAN FOR NAUSEA. THE PATIENT WAS ALSO GIVEN NAUSEA AND VOMITING MEDICATION TO TAKE HOME. THE SYMPTOMS KEPT ON GOING, AND ON (B)(6) 2019 THEY WENT TO THE HCP AND SAW A NURSE AND HCP. THEY TESTED THE PUMP BY INTERROGATING WHICH SHOWED A (B)(6) 2019 DATE AS THE REFILL DATE. A DYE STUDY WAS SCHEDULED FOR (B)(6) 2019. ON (B)(6) 2019 THE PATIENT WENT TO A DIFFERENT ER WHICH AGREED THAT THE PATIENT WAS EXPERIENCING WITHDRAWAL SYMPTOMS. THE PATIENT WAS GIVEN MEDS FOR THEIR STOMACH, IV DILAUDID, AND TORADOL. ON (B)(6) 2019 THE DYE STUDY WAS PERFORMED AND THE HCP TRIED TWO DIFFERENT KITS BUT WAS UNABLE TO WITHDRAW ANY FLUID AT ALL. THEY WERE TOLD IT WAS A CATHETER ISSUE AND WERE DIRECTED TO SEE A NEUROSURGEON. THE PATIENT'S SYMPTOMS STARTED TO LEVEL OUT BETWEEN (B)(6) 2019 AND WERE NOT SO BAD. THE PATIENT'S WITHDRAWAL SYMPTOMS RETURNED ON (B)(6) 2019 AND THEY SAW THE SURGEON ON THE SAME DATE. THE PATIENT RECEIVED ORAL DILAUDID (4MG EVERY 6 HOURS). THEY WERE GOING TO CHECK THE PUMP FIRST, AND WERE WAITING TO HEAR FROM THE SCHEDULER REGARDING THE SURGERY DATE. WHEN THEY ASKED THE SURGEON WHERE THE MEDICATION WAS GOING TO, THE SURGEON DIDN'T KNOW AND WAS TO CONTACT THE MANUFACTURER. THE CHANGE IN THERAPY/SYMPTOMS WAS CONSIDERED SUDDEN, AND THEY WERE TOLD BY THE HCP THAT THE WITHDRAWAL SYMPTOMS WERE NOT LIFE THREATENING. IT WAS NOTED THAT THE PATIENT'S NEXT REFILL DATE WOULD HAVE BEEN ON (B)(6) 2019 PROVIDED THE PATIENT USED ALL THEIR BOLUSES, BUT AT THE TIME OF REPORT THE SYSTEM SAID (B)(6) 2019. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421361 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20 00643169630505

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention