BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1242957 · Received November 21, 2008

    Report

    Report Number
    2182207-2008-07679
    Event Type
    Injury
    Date Received
    November 21, 2008
    Date of Event
    October 22, 2008
    Report Date
    October 28, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE HCP WAS UNABLE TO ACCESS THE CATHETER ACCESS PORT DURING A REFILL. THE PUMP WAS INVERTED AS THE SUTURES TYING THE PUMP TO THE FASCIA BROKE. A PUMP POCKET REVISION WAS DONE. THE PATIENT RECOVERED WITHOUT SEQUELA.

    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 65 YR Required Intervention PROGRAMMER: MODEL 8840| EXPLANTED: UNK| CATHETER: MODEL 8709