BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2053483 · Received March 1, 2011

    Report

    Report Number
    3004209178-2011-01512
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    January 1, 2011
    Report Date
    February 11, 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
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT EXPERIENCED A CHANGE IN THERAPY EFFECT. THE TYPE OF MEDICATION DELIVERED VIA THE PUMP WAS NOT REPORTED. THERE WAS A CATHETER ISSUE; FURTHER DETAILS OF THE ISSUE WERE UNK BY THE REPORTER. ADD'L INFO HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR EXPLANTED:| CATHETER: MODEL 8575, LOT# N091113| CATHETER: MODEL 8709, LOT# L64338| IMPLANTED:| EXPLANTED:| IMPLANTED: