BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 6012554 · Received October 7, 2016

    Report

    Report Number
    3004209178-2016-21366
    Event Type
    Injury
    Date Received
    October 7, 2016
    Date of Event
    September 29, 2016
    Report Date
    October 14, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4). A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 ON 06-OCT-2016 FROM MANUFACTURER'S REPRESENTATIVE (REP) STATED THAT IT WAS DETERMINED THAT THE PATIENT MUST HAVE HAD A POCKET FILL AT THE TIME OF LAST REFILL. THE PUMP REFILL WAS COMPLETED AND DOSING WAS RESUMED AND WITHDRAWAL SYMPTOMS RESOLVED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER VIA A MANUFACTURE'S REPRESENTATIVE REGARDING A PATIENT RECEIVING LIORESAL AT A CONCENTRATION OF 2000 MCG/ML AND A DOSE OF 370.4 MCG/DAY VIA AN IMPLANTABLE PUMP. THE INDICATION FOR USE WAS INTRACTABLE SPASTICITY. IT WAS REPORTED THE PATIENT WAS GOING THROUGH WITHDRAWAL AND EXPERIENCED INTENSE SPASMS STARTING LAST (B)(6). THE PUMP HAD BEEN REFILLED A FEW WEEKS AGO BUT THE EXACT DATE IS UNKNOWN. IT WAS BELIEVED THAT NO PUMP SETTINGS WERE CHANGED DURING THE PUMP REFILL. THE PATIENT ENDED UP GOING TO THE EMERGENCY ROOM AND X-RAYS, A DYE STUDY AND A CT SCAN WERE PERFORMED TO CONFIRM THE PUMP AND CATHETERS WERE IN TACT. THE COMPUTER READ THE PUMP AND STATED IT WAS FULL BUT THROUGH INTERROGATION AND ASPIRATION OF THE PUMP IT WAS DETERMINED THAT THE PUMP WAS EMPTY. THE PUMP WAS FILLED IMMEDIATELY. THE PATIENT SPENT 2 NIGHTS AT THE HOSPITAL AND 8 HOURS IN THE EMERGENCY ROOM DUE TO THE ISSUE. IT IS BELIEVED THE EMPTY PUMP WAS THE RESULT OF A POOR PUMP REFILL THAT OCCURRED 3 WEEKS AGO. THE WITHDRAWAL WAS VERY UNCOMFORTABLE FOR THE PATIENT AND THEY HAD EXTREME SPASTICITY THEY HAD NEVER EXPERIENCED BEFORE. IT WAS NOTED THAT THE PATIENT WENT SEVERAL HOURS WITHOUT RECEIVING MEDICATION AT THE HOSPITAL THAT LEAD TO A MORE EXTREME WITHDRAWAL EXPERIENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663491 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization