BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1243716 · Received November 25, 2008

    Report

    Report Number
    2182207-2008-07756
    Event Type
    Injury
    Date Received
    November 25, 2008
    Report Date
    October 31, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT MISSED A PUMP REFILL. THE PT EXPERIENCED RETURN OF SYMPTOMS AND PT WAS ADMITTED TO THE HOSP. THE PT'S PUMP WILL BE REFILLED.

    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 Hospitalization| R PROGRAMMER: MODEL 8840| EXPLANTED:| IMPLANTED:| CATHETER: MODLE 8709