BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2081340 · Received April 21, 2011

    Report

    Report Number
    3004209178-2011-02990
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 7, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED A RETURN OF SYMPTOMS. THERE WAS A VOLUME DISCREPANCY PROBLEM THAT WAS DISCOVERED AT THE PT'S 1ST REFILL SESSION SINCE IMPLANT. THE ACTUAL RESIDUAL VOLUME WAS 36ML AND THE EXPECTED RESIDUAL VOLUME WAS 6.4ML. THE PUMP LOGS DID NOT INDICATE ANY PROBLEMS. THE MEDICATION BEING DELIVERED VIA THE DEVICE WAS LIORESAL. IT WAS STATED THAT THE PT WAS DOING REMARKABLY WELL AND ONLY HAD SOME STIFFNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8596SC, LOT# N244344013| EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N256572004| IMPLANTED: