BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2244047 · Received August 24, 2011

    Report

    Report Number
    3004209178-2011-06798
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 5, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT PRESENTED AT THE CLINIC ON (B)(6) 2011 WITH AN INCREASE IN SPASTICITY AND ITCHING. THE PUMP WAS READ AND SHOWED THAT THE PUMP WAS IN "SAFE STATE." IT WAS UNKNOWN WHY THE PUMP WAS IN SAFE STATE. THE LAST REFILL WAS DONE ON (B)(6) 2011. THE HCP UPDATED THE PUMP WITH NEW SETTINGS AND THE PUMP UPDATED FINE. THEY ADJUSTED THE RESERVOIR VOLUME TO 26.5 ML. THE DEVICE SYSTEM WAS USED TO DELIVER GABLOFEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR IMPLANTED:| CATHETER: MODEL 8731SC, LOT# N134291016| EXPLANTED: