BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 4123275 · Received September 26, 2014

    Report

    Report Number
    6000030-2014-00134
    Event Type
    Injury
    Date Received
    September 26, 2014
    Report Date
    September 3, 2014
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8703, LOT # J92103160, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE EVENT OCCURRED WHEN THE PATIENT WAS IN FLORIDA WHEN THE PUMP WAS IMPLANTED. THE PATIENT WAS NOT PARALYZED. THE INJECTIONS WERE NOT THROUGH THE PUMP. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. ADDITIONAL INFORMATION COULD NOT BE OBTAINED AT THE TIME OF THE REPORT.  SHOULD ADDITIONAL BE RECEIVED A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WITH THE PATIENT'S FIRST PUMP IN 1993, THE STUDENT GAVE THE PATIENT 3 -4 SHOTS AND FINALLY IT KICKED IN. THE PATIENT WAS PARALYZED AND THEY COULDN¿T MOVE. (NO OUTCOME WAS REPORTED REGARDING THIS EVENT. IT WAS UNKNOWN WHAT THE PUMP SYSTEM WAS INFUSING AT THE TIME OF THE EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602831 SYNCHROMED PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK RICE CREEK MFG 8611H

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Other