BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1051457 · Received May 21, 2008

    Report

    Report Number
    2182207-2008-02673
    Event Type
    Malfunction
    Date Received
    May 21, 2008
    Date of Event
    April 18, 2007
    Report Date
    April 21, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED INTERMITTENT WITHDRAWAL SYMPTOMS OF SHAKING, MALAISE, NAUSEA, VOMITING, AND DIARRHEA. THE SYMPTOMS LASTED 8-12 HOURS. THE HCP REPORTED THAT THE SYMPTOMS SEEMED TO CORRELATED WITH PHYSICAL ACTIVITY, AND DID NOT CORRELATED WITH PUMP REFILLS. THE PUMP WAS REPROGRAMMED A FEW TIMES AND A SIDE ACCESS CATHETER STUDY WAS PERFORMED WHICH REVEALED THAT THE CATHETER WAS PATENT. AT THE PATIENT'S LAST REFILL (DATE NOT REPORTED) THE PATIENT'S PUMP WAS FILLED WITH SALINE. THE PT WAS SWITCHED TO ORAL MEDICATION AND IS BEING TREATED BY A DIFFERENT PHYSICIAN. THE PT'S PUMP CONTAINED DILAUDID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANTED| EXPLANTED| PROGRAMMER MODEL 8840| CATHETER MODEL 8731