BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2220247 · Received August 16, 2011

    Report

    Report Number
    3004209178-2011-06395
    Event Type
    Injury
    Date Received
    August 16, 2011
    Report Date
    July 21, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S HUSBAND FELT PUMP WAS "NOT WORKING." PER PHYSICIAN WHO COMPLETED INDIUM STUDY, THE DYE DID NOT LEAVE THE PUMP. THE PUMP WAS REPLACED. THE DRUG DELIVERED VIA THE PUMP WAS LIORESAL 2000MCG/ML, 700MCG/DAY. FOLLOWING SURGERY, THE PT WAS RESTARTED ON 50MCG/DAY, 500MCG/ML CONCENTRATION OF LIORESAL. NO ISSUES SINCE THE REPLACEMENT WERE REPORTED.

    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 Required Intervention IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N234498008