BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1062348 · Received June 18, 2008

    Report

    Report Number
    2182207-2008-03326
    Event Type
    Malfunction
    Date Received
    June 18, 2008
    Date of Event
    May 1, 2008
    Report Date
    May 3, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT PRESENTED WITH THE SYMPTOMS OF UNDERDOSE (NO SPECIFIC SYMPTOMS WERE REPORTED) AND THE PUMP WAS NOTED TO BE ALARMING. A ROTOR STUDY WAS PERFORMED (DATE NOT REPORTED) WHICH REVEALED A MOTOR STALL. THE PT'S PUMP WAS REPLACED. THE PT OUTCOME WAS NOT REPORTED. IT WAS REPORTED THAT THERE WAS NO PT INJURY. THE PT'S INJURY CONTAINED PETHIDINE 200 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention PROGRAMMER: MODEL 8840| CATHETER: MODEL CATHETER| EXPLANTED