BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2010569 · Received March 1, 2011

    Report

    Report Number
    3007566237-2011-01508
    Event Type
    Injury
    Date Received
    March 1, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 11, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL WITH A SLIGHTLY OPEN INCISION OVER HER PUMP WHICH WAS "OOZING BROWNISH FLUID". THE PUMP WAS EXPLANTED AND REPLACED DUE TO INFECTION. THE PUMP WAS USED TO DELIVER LIORESAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention CATHETER: MODEL 8709SC, LOT# N273386010| IMPLANTED:| EXPLANTED: