BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3180646 · Received June 20, 2013

    Report

    Report Number
    3004209178-2013-10661
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 28, 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 PRODUCTS: PRODUCT ID 8596SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER; PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A PUMP REPLACEMENT ON (B)(6) 2013 WHEN THE NEW PUMP WAS PROGRAMMED THE PATIENT EXPERIENCED ¿SIMILAR SYMPTOMS¿ TO A PREVIOUS OVERDOSE (REFER TO MANUFACTURER REPORT # 3004209178-2013-10658). NO INTERVENTION WAS TAKEN. THE PATIENT WAS WATCHED FOR ¿LIKE AN EXTRA HOUR¿ AND THE PUMP DOSE WAS DECREASED. THE DEVICE SYSTEM WAS USED TO DELIVER HYDROMORPHONE, CLONIDINE AND BUPIVACAINE. IT WAS LATER REPORTED THAT THE PATIENT EXPERIENCED A DROP IN BLOOD PRESSURE AND APPEARED SEDATED. THE REPORTER STATED THAT THE CATHETER WAS PATENT AND NO BREAK OR OCCLUSION WAS SUSPECTED. IT WAS LATER REPORTED THAT THE PATIENT¿S SYMPTOMS HAD RESOLVED AND WAS RECEIVING EFFECTIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281587 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Other