BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3142326 · Received June 3, 2013

    Report

    Report Number
    3004209178-2013-08524
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    April 2, 2012
    Report Date
    May 21, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SHORTLY AFTER THE ORIGINAL IMPLANT, THE PATIENT CONTINUED ON ORAL MEDICATIONS, OVERDOSED AND WAS ADMITTED TO THE HOSPITAL. (REFER TO MANUFACTURER REPORT # 3004209178-2013-05814) THE PATIENT OUTCOME WAS NOTED AS RECOVERED WITHOUT SEQUELA. IT WAS LATER REPORTED THAT THERE WAS NO PUMP ISSUE. THE PATIENT WAS OVERDOSED BECAUSE THE PATIENT WAS TAKING ORAL MEDICATION. THE PUMP WAS INITIALLY BEING USED TO DELIVER MORPHINE. THE MEDICATION IN THE PUMP WAS CHANGED TO SALINE ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243652 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Hospitalization