BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3830583 · Received May 23, 2014

    Report

    Report Number
    3004209178-2014-09582
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Report Date
    May 5, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD PROBLEMS WITH HIS PUMP SINCE IMPLANT AND THAT HE HADN¿T ¿BEEN FEELING GOOD¿. ACCORDING TO THE HEALTHCARE PROVIDER (HCP), THE PUMP WAS MALFUNCTIONING IN SPRING 2012. THE MALFUNCTION HAD SOMETHING TO DO WITH THE DOSAGE. THE PATIENT HAD BEEN VOMITING FOR 5 DAYS. IT WAS NOTED THAT, AT THE TIME OF THE INCIDENT, THE PATIENT¿S HYDROMORPHONE DOSE WAS MUCH LOWER THAN THE CURRENT DOSE. IT WAS ALSO REPORTED THAT THE SIDE EFFECTS FROM THE HYDROMORPHONE WERE TERRIBLE. THE PUMP WAS TAKING CARE OF THE PATIENT¿S LUMBAR PAIN, BUT THEY WERE INCREASING THE DOSE TO TAKE CARE OF HIS THORACIC PAIN. IT WAS NOTED THAT THE PATIENT COULDN¿T TOLERATE MORPHINE IN HIS PUMP. THE PATIENT¿S HCP DIDN¿T SEEM TO CARE ABOUT THE PATIENT¿S ISSUES OR SYMPTOMS. HE WAS SUPPOSED TO RECEIVE A PERSONAL THERAPY MANAGER (PTM), BUT DID NOT. THE DEVICE SYSTEM WAS USED TO DELIVER HYDROMORPHONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308665 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR