BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3874480 · Received June 16, 2014

    Report

    Report Number
    3004209178-2014-11626
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    May 26, 2014
    Report Date
    May 28, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP REVEALED NO SIGNIFICANT ANOMALY. THE ELECTIVE REPLACEMENT INDICATOR (ERI) WAS DUE TO TIME PROGRESSION. CONCLUSION: NO LONGER APPLIES TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED SEVERE UNDERDOSE SYMPTOMS STARTING (B)(6) 2014, WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU), WAS INTUBATED AND PUT ON A VENTILATOR. THE LOGS WERE CHECKED AND X-RAYS WERE PERFORMED, THE RESULTS WERE NOT PROVIDED. THERE WAS NO ALLEGED PRODUCT ISSUE, BUT IT WAS DECIDED TO EXPLANT THE PUMP AND ASPIRATE THE CATHETER, WHICH REMAINED IMPLANTED. IT WAS NOTED THAT 5 ML WERE EASILY ASPIRATED AND A NEW PUMP WAS CONNECTED. THEN 7ML WERE ASPIRATED FROM THE OLD PUMP, WHICH WAS ACCORDING TO THE PROGRAMMER AS WELL. THE PATIENT STATUS AT THE TIME OF THE REPORT WAS ALIVE NO INJURY. THE PUMP WAS BEING USED TO DELIVER BACLOFEN.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE UNDERDOSE WAS PROBABLY CAUSED BY A CATHETER PROBLEM AND THE PATIENT WAS CURRENTLY DOING ¿FINE.¿ ADDITIONAL INFORMATION WAS REQUESTED TO VERIFY THE CATHETER ISSUE AND IF A REVISION OF THE CATHETER HAD BEEN PERFORMED. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THE REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352063 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R