BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1950057 · Received December 7, 2010

    Report

    Report Number
    3004209178-2010-10285
    Event Type
    Malfunction
    Date Received
    December 7, 2010
    Date of Event
    September 1, 2010
    Report Date
    November 30, 2010
    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

    IT WAS REPORTED THAT IN SEPTEMBER, AN ALARM WAS HEARD; THIS WAS NOT CONFIRMED BY TELEMETRY. THE PT REPORTED INCREASED BASELINE PAIN. OVER THE THANKSGIVING HOLIDAY, THE PT THOUGHT HE WAS EXPERIENCING WITHDRAWAL AS HE WAS IN PAIN. HE THOUGHT THAT THE CATHETER MAY HAVE DISLODGED. IT WAS ALSO REPORTED THAT THE PT THOUGHT HE HEARD A BEEP. THE PT WAS SEEN BY THE HEALTHCARE PROFESSIONAL AND IT WAS BELIEVED THAT A ROTOR AND DYE STUDY WAS PERFORMED AND THE PUMP WAS FINE; RESULTS OF THE DYE STUDY WERE NOT REPORTED. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    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 53 YR EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N258708004| IMPLANTED: