BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2063775 · Received April 15, 2011

    Report

    Report Number
    3007566237-2011-02856
    Event Type
    Injury
    Date Received
    April 15, 2011
    Report Date
    March 31, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS "DEVELOPING A LUNG PNEUMONIA." THE PT DEVELOPED A CELLULITIS AT THE PUMP POCKET SITE; THE POCKET WAS "APPARENTLY COMPROMISED." THE DRUG SYS WAS EXPLANTED DUE TO THE INFECTED POCKET SITE. THE SYS WAS NOT REPLACED. THE PUMP CONTAINED MORPHINE 20 MG/ML AND ROPIVACAINE. PER THE REPORTER, THERE WAS NO INJURY AND THE PT RECOVERED WITHOUT SEQUELAE.

    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 Required Intervention EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8703W, LOT# L40095