BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2052638 · Received April 7, 2011

    Report

    Report Number
    3004209178-2011-02665
    Event Type
    Injury
    Date Received
    April 7, 2011
    Date of Event
    March 23, 2011
    Report Date
    April 1, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED OVERDOSE SYMPTOMS AFTER HAVING THE PUMP UPDATED; IT WAS THOUGHT ONLY A DOSE CHANGE WAS MADE AND NOT A REFILL. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND INTUBATED. SHE WAS DISCHARGED ON (B)(6) 2011. AS OF (B)(6) 2011, THE PATIENT WAS STABLE. AN MRI WAS DONE (B)(6) 2011 (REASON NOT REPORTED); PUMP RECOVERY WAS NOTED AFTER THE MRI. THE DEVICE SYSTEM WAS USED TO DELIVER MORPHINE (25 MG/ML), BACLOFEN (3,045 MCG/ML), AND CLONIDINE (500 MCG/ML).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization CATHETER: MODEL 8709, LOT# J11681R27| IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8578, LOT# N145718| IMPLANTED:| PROGRAMMER: MODEL 8840, LOT# UNKNOWN| EXPLANTED: