BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2050037 · Received March 31, 2011

    Report

    Report Number
    3004209178-2011-02436
    Event Type
    Malfunction
    Date Received
    March 31, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 18, 2011
    Manufacturer
    MEDTRONIC 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS FLIPPED. A VOLUME DISCREPANCY WAS ALSO REPORTED WITH AN ACTUAL RESIDUAL VOLUME OF ABOUT 20ML AND THE EXPECTED RESIDUAL VOLUME OF ABOUT 2ML. A CRITICAL ALARM HAD ALSO OCCURRED DUE TO A LOW RESERVOIR AND AN EMPTY RESERVOIR. THE PUMP SHOWED THAT 37.7 ML WAS DISPENSED SINCE THE LAST UPDATE ON (B)(6) 2011. NO PATIENT SYMPTOMS WERE REPORTED. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT PROVIDED. 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 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709SC, LOT# N262495008