BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2890421 · Received December 30, 2012

    Report

    Report Number
    3004209178-2012-12374
    Event Type
    Injury
    Date Received
    December 30, 2012
    Date of Event
    November 30, 2012
    Report Date
    November 30, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 8709 SERIAL# (B)(4), IMPLANTED: 2001 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN OVERDOSE. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) AFTER PRESENTING TO THE EMERGENCY ROOM (ER) SYMPTOMATIC FOR POTENTIAL OVERDOSE. THE HEALTHCARE PROVIDER (HCP) INDICATED THAT NARCAN WAS ADMINISTERED TO THE PATIENT, AND PUMP WAS DECREASED 25%. THE PUMP HAD NO PENDING ALARMS. MEDICATIONS IN THE PUMP WERE BACLOFEN 200MCG/ML WITH A DOSE OF 35.97MCG/DAY, AND INFUMORPH 50MG/ML WITH A DOSE OF 8.993MG/DAY. NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS LATER REPORTED THAT WHEN THE PATIENT'S PUMP WAS REFILLED ON (B)(6) 2012, THE MORPHINE DOSE WAS 8.993 MG/DAY AND THE BACLOFEN WAS 35.97 MCG/DAY. THE PATIENT THEN EXPERIENCED OVERDOSE SYMPTOMS. THE DOSE WAS THEN DECREASED BY APPROXIMATELY 4% ON (B)(6) 2012. THE DRUG DOSES WERE MORPHINE 6.475 MG/DAY AND BACLOFEN 26.98 MCG/DAY. ADDITIONALLY, THE HCP REPORTED THAT THE PATIENT'S PUMP CONTAINED A 50-MG/ML CONCENTRATION OF MORPHINE AND A 200-MCG/ML CONCENTRATION OF BACLOFEN. ONCE THE PATIENT STABILIZED AND THE SYMPTOMS RESOLVED, THE DOSES WERE SLIGHTLY INCREASED TO THE CURRENT DOSE OF MORPHINE 6.995 MG/DAY AND BACLOFEN 27.98 MCG/DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Hospitalization| R