BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1011288 · Received March 11, 2008

    Report

    Report Number
    2182207-2008-01195
    Event Type
    Injury
    Date Received
    March 11, 2008
    Report Date
    February 11, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT DEVELOPED AN INFECTION OF THE PUMP POCKET SEVERAL MONTHS AFTER IMPLANT. THE ENTIRE SYSTEM WAS REMOVED. NO PT SYMPTOMS WERE REPORTED. THE PUMP WAS USED TO DELIVER BACLOFEN. ADD'L INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Required Intervention IMPLANTED:| IMPLANTED:| CATHETER MODEL 8709 LOT# J12568R16| EXPLANTED:| PROGRAMMER MODEL 8840 LOT# UNK| EXPLANTED: