BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3071271 · Received April 22, 2013

    Report

    Report Number
    3004209178-2013-06670
    Event Type
    Injury
    Date Received
    April 22, 2013
    Date of Event
    March 25, 2013
    Report Date
    June 24, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8781, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013. PRODUCT TYPE: CATHETER: PRODUCT ID 8835, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE PATIENT'S PAIN WAS WELL CONTROLLED AND THEY WERE "DOING MUCH BETTER".

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A PUMP IMPLANT THE PATIENT EXPERIENCED LEFT LEG PARALYSIS. THE PATIENT WAS HOSPITALIZED AT THE TIME OF THE REPORT AND BEING TREATED BY THE MANAGING PHYSICIANS. IT WAS NOT KNOWN WHAT MEDICATION THE DEVICE SYSTEM DELIVERED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    THE REPORTER ¿BELIEVED¿ THE CAUSE OF THE EVENT WAS IRRITATION FROM IMPLANT PROCEDURE AND THE LEFT LEG PARALYSIS WAS NOTED AS ¿ALL RE SOLVED.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172743 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Hospitalization