BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1872783 · Received October 14, 2010

    Report

    Report Number
    3004209178-2010-07984
    Event Type
    Injury
    Date Received
    October 14, 2010
    Date of Event
    January 1, 2008
    Report Date
    September 17, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED SWELLING IN THE RIGHT LEG. AS A RESULT, THE PATIENT'S PHYSICIAN DECREASED THE MORPHINE AND ADDED DILAUDID IN THE PATIENT'S PUMP. NO INFORMATION WAS PROVIDED REGARDING THE CONCENTRATION OR DOSAGE OF THE MEDICATIONS USED IN THE PATIENT'S PUMP. THE PATIENT ALSO HAD AN INCREASED LEVEL OF ANXIETY, SINCE HAVING THE PUMP IMPLANTED. THE PATIENT STATED THAT THERE WERE SLEEP DISTURBANCES RELATED TO THE ANXIETY. THE PATIENT ALSO REPORTED WEIGHT GAIN AND (UNSPECIFIED) INFECTION, FOLLOWING THE IMPLANTATION OF THE PUMP. THE PATIENT STATED THAT THE PHYSICIAN WAS ASKED, BY THE PATIENT, TO REMOVE THE PUMP. THE NEXT LOW RESERVOIR ALARM, OR REFILL DATE, WAS STATED TO BE ON (B)(6) 2010. THE PATIENT WAS TO MEET WITH THE PHYSICIAN TO HAVE THE PUMP REFILLED ON (B)(6) 2010. NO FURTHER DETAILS WERE PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Required Intervention CATHETER: MODEL 8709SC, LOT# N153696007| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709SC, LOT# N153696007| IMPLANTED:| EXPLANTED: