BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2070173 · Received April 25, 2011

    Report

    Report Number
    3004209178-2011-03062
    Event Type
    Injury
    Date Received
    April 25, 2011
    Date of Event
    March 30, 2011
    Report Date
    April 9, 2011
    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
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PUMP WAS FILLED WITH NORMAL SALINE AND PROGRAMMED TO A MINIMUM RATE "FOR A LONG TIME." AFTER THE PT LOST WEIGHT, THE PT UNDERWENT SURGERY TO REPLACE A 40 ML PUMP WITH A 20 ML PUMP, AND REPOSITION THE PUMP LOCATION FROM THE PT'S STOMACH TO THE BACKSIDE. THE CATHETER WAS REPLACED DUE TO A "BREAK, TEAR, HOLE." IT WAS NOT REPORTED IF THE CATHETER ISSUE WAS DETERMINED PRIOR TO SURGERY. THE PT OUTCOME WAS NOT REPORTED. ADD'L 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 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709SC, LOT# N146671010