BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1082625 · Received July 25, 2008

    Report

    Report Number
    3004209178-2008-04426
    Event Type
    Injury
    Date Received
    July 25, 2008
    Report Date
    July 1, 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
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    USED FOR THE CATHETER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S PUMP WAS REPLACED IN 2008. THE HCP "DETECTED" HOLES IN THE CATHETER. THE PT STATED THAT THE EXPLANTED PUMP WAS NOT CONTROLLING PAIN SYMPTOMS, AND THE HCP DETERMINED THAT IT WAS NOT DELIVERING MEDS PROPERLY. 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 CATHETER MODEL #: 8711| IMPLANTED:| PROGRAMMER MODEL 8840 LOT# UNK