BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 8046387 · Received November 7, 2018

    Report

    Report Number
    3004209178-2018-24864
    Event Type
    Injury
    Date Received
    November 7, 2018
    Date of Event
    October 21, 2018
    Report Date
    November 7, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00643169530126
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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 CONSUMER VIA A COMPANY REPRESENTATIVE REGARDING A PATIENT RECEIVING MORPHINE 1MG/ML AT 0.048 MG/DAY VIA AN IMPLANTABLE PUMP. THE INDICATION FOR USE WAS NON-MALIGNANT PAIN. THE PATIENT'S MEDICAL HISTORY INCLUDED AN UNSPECIFIED BRAIN INJURY. ON (B)(6) 2018 IT WAS REPORTED THAT THE PATIENT HAD CALLED THE COMPANY REPRESENTATIVE SAYING THAT SHE WAS SEEING ¿NUMBERS AND LETTERS¿ ON HER SKIN AND ALL OVER HER BODY. THE PATIENT STATED THAT HER HEAD FELT ¿SWIMMY¿ AND THAT THIS ALL STARTED TODAY. THE PATIENT WANTED THE PUMP TURNED OFF NOW. THE COMPANY REPRESENTATIVE ADVISED THE PATIENT THAT IF SHE WANTED TO GO TO THE ER (EMERGENCY ROOM) THEY COULD CALL THE MANAGING PHYSICIAN AND IF HE WANTED THE PUMP TURNED OFF THEY WOULD CONTACT THE COMPANY REPRESENTATIVE TO GO TO THE ER (EMERGENCY ROOM). OTHERWISE IF THE PATIENT FELT OK TO CALL THE MANAGING PHYSICIAN TOMORROW AND TALK TO THEIR OFFICE ABOUT HOW TO PROCEED. IT WAS UNKNOWN IF THERE WERE ANY ENVIRONMENTAL, EXTERNAL OR PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. THE ISSUE WAS NOT RESOLVED AT THE TIME OF THE REPORT. ON (B)(6) 2018 ADDITIONAL INFORMATION WAS RECEIVED THAT REPORTED THE PATIENT CLAIMED TO BE HAVING HALLUCINATIONS AND FELT THAT THEY WERE RELATED TO THE PATIENT'S DEVICE. THE PATIENT WAS REFERRED TO THEIR MANAGING NEUROLOGIST. THE PATIENT'S PUMP WAS TURNED DOWN TO THE LOWEST SIMPLE CONTINUOUS RATE ACCORDING TO THE PHYSICIAN'S ASSISTANT. ONLY MORPHINE WAS INFUSING AT THE TIME OF THE EVENT. IT WAS UNKNOWN IF THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. SURGICAL INTERVENTION DID NOT OCCUR NOR WAS IT PLANNED. THE PATIENT STATUS WAS NOTED AS ALIVE, NO INJURY AND NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885859 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40 00643169530126

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other