BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3043189 · Received April 9, 2013

    Report

    Report Number
    3004209178-2013-04912
    Event Type
    Injury
    Date Received
    April 9, 2013
    Report Date
    March 11, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8781, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WENT TO THE SAME HOSPITAL REHABILITATION. TWO DAYS AFTER THE PATIENT LEFT THE HOSPITAL REHABILITATION FACILITY, HE PRESENTED WITH SEVERE SPASMS AND BREATHING DIFFICULTIES. THE PATIENT WAS NOT INTUBATED AND IT APPEARED THE SYMPTOMS SUBSIDED. THE NURSING HOME WOULD NOT TAKE THE PATIENT BACK AS THEY BELIEVED WITH THE PUMP AND THE PATIENT BEING ON MANY ORAL MEDICATIONS POSED A DANGER, AND THEY WERE CONCERNED ABOUT RESPIRATORY DEPRESSION. THE FAMILY BELIEVED MORE SHOULD HAVE BEEN DONE. THE PATIENT REQUIRED HOSPITALIZATION. THE PUMP SYSTEM WAS BEING USED TO DELIVER LIORESAL. 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
    144999 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Hospitalization