BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 5750924 · Received June 27, 2016

    Report

    Report Number
    3004209178-2016-12931
    Event Type
    Injury
    Date Received
    June 27, 2016
    Date of Event
    March 20, 2013
    Report Date
    August 19, 2016
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: SEX, DATE OF BIRTH. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A CLINICAL STUDY. THE INTRATHECAL MEDICATION WAS MORPHINE (CONCENTRATION 25 MG/ML, DOSE 4.714 MG/DAY) AND BACLOFEN (CONCENTRATION 4220 MCG/ML, DOSE 795.8 MCG/DAY) PER PUMP SETTINGS AS EXAMINED ON (B)(6) 2012. THE EVENT WAS POSSIBLY RELATED TO INCREASED DOSE.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A PHYSICIAN VIA THE PRODUCT SURVEILLANCE REGISTRY REGARDING A PATIENT RECEIVING INTRATHECAL COMPOUNDED BACLOFEN 4 ,220.0 MCG/ML AND MORPHINE 25MG/ML VIA AN IMPLANTABLE INFUSION PUMP FOR NON-MALIGNANT PAIN AND FAILED BACK SYNDROME-OTHER. PER THE PUMP LOGS FROM (B)(6) 2012, THE PUMP WAS PROGRAMMED TO DELIVER COMPOUNDED BACLOFEN 795.8 MCG/DAY AND MORPHINE 4.714 MG/DAY. ON THAT SAME DATE THE PUMP DOSE WAS INCREASED TO COMPOUNDED BACLOFEN 836.2 MCG/DAY AND MORPHINE 4.954 MG/DAY. THE PATIENT EXPERIENCED HYPERSOMNOLENCE, FREQUENT FALLS AND MEMORY PROBLEMS. THE PROGRAMMING DATE FROM THE MOST RECENT REFILL WAS (B)(6) 2012. ON (B)(6) 2013, THE NURSE PRACTITIONER NOTICED THE PATIENT FALLING ASLEEP DURING THE VISIT. THE PATIENT WOULD QUIT TALKING AND HER ARM WOULD GO LIMP AND SHE WOULD LOOK LIKE SHE WAS SLEEPING. THERE WAS CONCERN THAT THE PUMP MEDICATION COULD BE CONTRIBUTING TO HYPERSOMNOLENCE SO THE PUMP WAS REPROGRAMMED. ON (B)(6) 2013, THE PUMP DOSE WAS ADJUSTED DOWNWARD FOR SUSPICION OF POSSIBLE SLEEP APNEA EXACERBATION FROM PUMP MEDICATIONS. THE PHYSICIAN DID NOT BELIEVE THAT THE PUMP WAS CONTRIBUTING TO THE TENDENCY TO FALL. ON (B)(6) 2014, MEMORY PROBLEMS WERE REPORTED SO THE PUMP WAS TURNED DOWN; HOWEVER, IT WAS NOTED ON (B)(6) 2014 THAT IT DID NOT HELP WITH THE MEMORY PROBLEMS. IN REGARDS TO THE RELATIONSHIP OF THE EVENT TO THE DEVICE OR THERAPY, IT WAS UNLIKELY RELATED, NOT RELATED TO THE IMPLANT PROCEDURE AND POSSIBLY RELATED TO THE INCREASE IN THE PUMP MEDICATION. AS OF (B)(6) 2014, THE OUTCOME OF THE EVENT WAS RESOLVED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406387 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other| R