BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2955270 · Received February 11, 2013

    Report

    Report Number
    3004209178-2013-02511
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    January 15, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH THE PUMP AND THAT A PUMP REPLACEMENT WAS PLANNED. REPORTER STATED THAT THE PATIENT WAS FINE UP TO A MONTH AGO, WHEN THE "PUMP STOPPED." THE REPORTER NOTED THAT THE REPLACEMENT DATE WAS UNKNOWN AND WAS PENDING NOTIFICATION FROM THE HEALTHCARE PROVIDER (HCP), BUT THAT IT WAS TO BE REPLACED. IT WAS ALSO NOTED THAT DURING A RECENT DYE STUDY, THE HCP WAS ALSO UNABLE TO PUSH CONTRAST THROUGH THE PUMP. THE DRUG IN THE PUMP WAS DILAUDID. NO FURTHER EVENT DETAILS WERE PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A NON-SERIOUS INJURY/ILLNESS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59318 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention