BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2003707 · Received February 24, 2011

    Report

    Report Number
    3004209178-2011-01415
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    December 8, 2010
    Report Date
    February 7, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT HAD "CONCENTRATED" MORPHINE IN THE PUMP. THE PT'S LAST REFILL WAS (B)(6) 2010. PER THE RPTR, THE PUMP WAS REFILLED WITH HYDROMORPHONE. ON (B)(6) 2010, THE PT BECAME VIOLENTLY ILL WITH SEVERE VOMITING, DEHYDRATION, AND WAS DISORIENTED. THE PT WAS HOSPITALIZED. THE HCPS (HEALTHCARE PROFESSIONALS) BELIEVED THE PT WAS HAVING SEIZURES. PER THE RPTR, THE HCP TOLD THE PT HE EXPERIENCED "WITHDRAWAL" AS A RESULT OF TAKING OTHER MEDICATIONS THAT WERE NOT PRESCRIBED BY THE HCP. AS OF (B)(6) 2011, THE PT CONTINUED TO EXPERIENCE THE "SEVERE SYMPTOMS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| O IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8731SC, LOT# N237431002