BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3123916 · Received May 22, 2013

    Report

    Report Number
    3004209178-2013-08025
    Event Type
    Injury
    Date Received
    May 22, 2013
    Date of Event
    September 13, 2012
    Report Date
    April 22, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: CATHETER: PRODUCT ID 8835, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2012 THAT PATIENT HAD EXPERIENCED MEDICATION SIDE EFFECTS OF MORPHINE. IT WAS ADDED THAT PATIENT SHOWED SYMPTOMS OF DROWSINESS, CONFUSION, WILD DREAMS AND AUDITORY HALLUCINATIONS FOLLOWING A PERSONAL THERAPY MANAGER BOLUS THE NEXT DAY. THE INFUSION DRUG WAS CHANGED TO HYDROMORPHONE TWO DAYS AFTER THE REPORTED DATE AND THE PATIENT OUTCOME AS INDICATED AS RESOLVED WITHOUT SEQUELAE AS OF (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225858 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Other| R