BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2093947 · Received May 16, 2011

    Report

    Report Number
    3004209178-2011-03534
    Event Type
    Injury
    Date Received
    May 16, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 22, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S SYSTEM WAS REMOVED DUE TO INFECTION. THE DRUG THAT WAS IN THE PUMP AT THE TIME THE EVENT WAS REPORTED WAS NOT KNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention EXPLANTED:| IMPLANTED:| IMPLANTED:| CATHETER: MODEL 8598A, LOT# N250499006| EXPLANTED:| CATHETER: MODEL 8596SC, LOT# N244344009