BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1181197 · Received September 30, 2008

    Report

    Report Number
    3004209178-2008-06225
    Event Type
    Injury
    Date Received
    September 30, 2008
    Date of Event
    August 1, 2008
    Report Date
    September 4, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    FOLLOWING A PUMP REPLACEMENT, THE PATIENT HAD AN INFECTION ON OR OVER THE PUMP LOCATION. THE PATIENT WAS TAKEN TO THE OPERATING ROOM; THE HEALTH CARE PROFESSIONAL WAS CONSIDERING REPLACING THE PUMP WITH THE ACTIVE INFECTION. THE MEDICATION BEING DELIVERED VIA THE PUMP WAS NOT REPORTED. 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 PUERTO RICO OPERATIONS CO. 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED| CATHETER MODEL 8711| PROGRAMMER MODEL 8840