BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3243636 · Received July 23, 2013

    Report

    Report Number
    3004209178-2013-12199
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Report Date
    June 30, 2013
    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
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8840, PRODUCT TYPE: PROGRAMMER. PHYSICIAN PRODUCT ID: 8731SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    A HEALTHCARE PROVIDER REPORTED THAT PRIALT WAS ADDED TO THE PATIENT¿S DRUG COCKTAIL ON (B)(6) 2013, WHICH INCLUDED BUPIVACAINE, DILAUDID, AND BACLOFEN. THE PATIENT BEGAN RECEIVING THE ADDED DRUG ON (B)(6) 2013. THE PATIENT EXPERIENCED CONSTIPATION ALONG WITH URINARY RETENTION THAT PROGRESSED ALONG WITH THE CONSTIPATION ISSUES. THE PATIENT GAVE THEMSELVES AN ENEMA AND HAD A BOWEL MOVEMENT, BUT THEY HAD NOT HAD A BOWEL MOVEMENT SINCE (B)(6) 2013. THE PATIENT HAD TO BE CATHETERIZED ON (B)(6) 2013 WITH 525 CC OF URINE OUTPUT. THEY WERE CATHETERIZED AGAIN ON (B)(6) 2013 WITH 425 CC OF URINE OUTPUT. ON (B)(6) 2013 A FOLEY CATHETER WAS INSERTED. THE PATIENT SAW THEIR DOCTOR ON (B)(6) 2013 AND IT WAS DECIDED TO REMOVE THE PRIALT FROM THE DRUG COCKTAIL BECAUSE OF THE PATIENT¿S SYMPTOMS. PRIALT WAS REMOVED ON (B)(6) 2013 AND A BRIDGE BOLUS WAS PROGRAMMED. THE CALLER HAD DIFFICULTIES WITH INTERRUPTED TELEMETRY. THE CALLER WAS ASSISTED WITH REMOVING SOURCES OF EMI IN THE VICINITY OF THE 8840 PROGRAMMER AND PUMP, AND THEN THE CALLER WAS SUCCESSFUL WITH TELEMETRY AND UPDATING THE PUMP. IT WAS LATER REPORTED THAT ON (B)(6) 2013, THE PATIENT¿S BUPIVACAINE DOSE WAS INCREASED. ON (B)(6) 2013 THE PATIENT¿S FOLEY CATHETER WILL BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342834 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR