BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1222426 · Received November 5, 2008

    Report

    Report Number
    6000030-2008-07220
    Event Type
    Injury
    Date Received
    November 5, 2008
    Date of Event
    September 1, 2008
    Report Date
    October 9, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0955-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED A RETURN OF SYMPTOMS FOLLOWING A PUMP REFILL SESSION. THEY WERE REFILLING THE PUMP WHEN THE RESERVOIR WAS BETWEEN 1-2 MLS. THE HEALTH CARE PROFESSIONAL PLANNED TO BRING THE PATIENT BACK ONE WEEK EARLY FOR THE NEXT REFILL TO SEE IF THAT RESOLVED THE ISSUE. IT WAS LATER REPORTED, THAT THE PUMP WAS REPLACED FOR A POSSIBLE ROTOR MALFUNCTION. THERE WAS NO PATIENT INJURY. THE PATIENT RECOVERED WITHOUT SEQUELA. THE PUMP WAS USED TO DELIVER LIORESAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK RICE CREEK MANUFACTURING 8627L10 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED:| EXPLANTED:| PROGRAMMER MODEL PROGRAMMER LOT# UNK| CATHETER MODEL 8709 LOT# J11743R28