BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3781516 · Received April 30, 2014

    Report

    Report Number
    3004209178-2014-08262
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 8, 2014
    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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP FOUND NO ANOMALY.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), EXPLANTED: 2014 (B)(6); PRODUCT TYPE CATHETER. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE CATHETER AND PUMP WERE EXPLANTED AND REPLACED ON 2014 (B)(6) DUE TO A CATHETER OCCLUSION. THERE WAS NO ALLEGED PRODUCT ISSUE REGARDING THE PUMP AND THE CATHETER WAS DISCARDED. IT WAS NOTED, THE LOCATION OF THE OCCLUSION WAS UNKNOWN AND THE CAUSE OF THE ISSUE WAS UNDETERMINED. IT WAS ALSO REPORTED, A DYE STUDY WAS PERFORMED ON AN UNSPECIFIED DATE. PATIENT SYMPTOMS INCLUDED INCREASED SPASTICITY AT AN UNKNOWN LOCATION. IT WAS REPORTED, THE PATIENT¿S STATUS ON THE DATE OF THIS REPORT WAS ¿ALIVE- NO INJURY.¿ THE PUMP WAS BEING USED TO DELIVER LIORESAL. IT WAS FURTHER REPORTED, THE LOCATION OF THE OCCLUSION WAS NEVER DETERMINED. IT WAS NOTED, THE PUMP WAS REPLACED BECAUSE, THE CAUSE OF THE OCCLUSION COULD NOT BE DETERMINED. IT WAS ALSO REPORTED, THE PATIENT WAS ¿DOING GOOD¿ AND RECEIVING THERAPY. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT WHEN IT BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260246 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Required Intervention