BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1842090 · Received September 20, 2010

    Report

    Report Number
    3004209178-2010-07100
    Event Type
    Injury
    Date Received
    September 20, 2010
    Date of Event
    August 19, 2010
    Report Date
    August 19, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS TAKEN TO THE EMERGENCY ROOM WITH SOME "SIGNS OF OVERDOSE" ONE DAY AFTER A PUMP REPLACEMENT. THE CATHETER WAS NOT REPLACED WITH THE PUMP. THE DOCTOR COMPARED THE DOSING, CATHETER VOLUMES, AND DRUG IN THE PUMP PRE-REPLACEMENT WITH POST-REPLACEMENT STRIP IN THE CHART. THERE WAS NO CHANGE IN DOSING, CATHETER VOLUME, OR DRUG CONCENTRATION. PT'S FAMILY MEMBER HAD INDICATED THAT THE PT WAS INCOHERENT. WHEN THE PT ARRIVED IN THE EMERGENCY ROOM SHE WAS ALERT, AWAKE, AND COMMUNICATING APPROPRIATELY. THE DOCTOR HAD WANTED TO DECREASE THE PT'S PUMP TO MINIMUM RATE BUT THE PT PROTESTED FOR FEAR OF WITHDRAWAL. THE EMERGENCY ROOM DOCTOR CUT THE DOSE IN HALF (FROM 18 MG/DAY TO 9 MG/DAY). IT WAS UNK IF DEVICE TROUBLESHOOTING WAS PERFORMED. THE PT'S STATUS WAS UNDETERMINED AT THE TIME OF THE REPORT. THE PUMP CONTAINED MORPHINE AT A CONCENTRATION OF 30 MG/ML WITH BUPIVACAINE AT A CONCENTRATION OF 10 MG/ML. ADDITIONAL INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention EXPLANTED:| CATHETER: MODEL 8731, LOT# N001904020| IMPLANTED: