BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1051469 · Received May 21, 2008

    Report

    Report Number
    2182207-2008-02686
    Event Type
    Malfunction
    Date Received
    May 21, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 21, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE SHOULD HAVE BEEN ONLY 2 DAYS OF MEDICATION LEFT IN THE PUMP; INSTEAD, NEARLY THE FULL AMOUNT OF MEDICATION FROM A PUMP REFILL 6 MONTHS AGO REMAINED. THE PT HAD BEEN ADMITTED TO THE HOSPITAL DUE TO MANY OTHER MEDICAL PROBLEMS. THE PT'S CONDITION WAS FAIR. THE TYPE OF MEDICATION ADMINISTER BY THE PUMP WAS NOT REPORTED. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.

    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 Hospitalization| R CATHETER MODEL 8709 LOT# N070768008| EXPLANTED| PROGRAMMER MODEL 8840 LOT# UNK