BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1063045 · Received June 19, 2008

    Report

    Report Number
    3004209178-2008-03356
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Report Date
    May 23, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    REFERS TO THE CATHETER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD A CATHETER ISSUE (UNSPECIFIED). THE PT UNDERWENT A CATHETER REVISION. THE PT OUTCOME WAS NOT REPORTED. THE DRUG CONTAINED IN THE PT'S PUMP WAS NOT REPORTED. ADD'L INFO HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED:| CATHETER MODEL 8709| PROGRAMMER MODEL 8840