BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2172587 · Received July 20, 2011

    Report

    Report Number
    3004209178-2011-05619
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    January 1, 2011
    Report Date
    June 29, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    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 EXPERIENCED WITHDRAWAL AND A RETURN OF PAIN SYMPTOMS. THE PT WAS ON THE OPERATING ROOM AT THE TIME THE EVENT WAS REPORTED. THERE WAS ALSO A CATHETER ACCESS PORT ISSUE, THE HEALTH CARE PROVIDER WAS HAVING DIFFICULTY ASPIRATING FLUID THROUGH THE ACCESS PORT. THE PT WAS HAVING A REVISION DONE AT THE TIME THE EVENT WAS REPORTED. AT THE PREVIOUS REVISION, THE HEALTH CARE PROVIDER WAS UNABLE TO ASPIRATE DURING A DYE STUDY. AFTER THE POCKET WAS OPENED AND DISCONNECTED THE CATHETER FROM THE PUMP, CSF BACKFLOW WAS PRESENT. ONCE THE CATHETER AND PUMP WERE CONNECTED AGAIN, THEY WERE ABLE TO ASPIRATE, BUT FLOW WAS NOT AS FREE AS THE HEALTH CARE PROVIDER WOULD HAVE LIKED. THE PLAN WAS TO REPLACE A PORTION OF THE CATHETER AND TRY ASPIRATING AGAIN. THE DRUG USED IN THE PUMP AT THE TIME OF THE EVENT WAS NOT REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED; A F/U REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    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 59 YR Required Intervention EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT# N281971010