BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3223508 · Received July 12, 2013

    Report

    Report Number
    3004209178-2013-11672
    Event Type
    Injury
    Date Received
    July 12, 2013
    Report Date
    June 18, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709SC LOT# SERIAL# (B)(4), IMPLANTED: 2011 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD BEEN CONTINUOUSLY SICK SINCE THE IMPLANT OF THE NEW PUMP AND CATHETER. SHE WAS EXPERIENCING NAUSEA AND HAD ALSO LOST 13 LBS. THE PATIENT¿S PHYSICIAN HAD RECOMMENDED THE USE OF COMPAZINE, BUT IT HAD NOT HELPED. FOLLOWING THAT, THE PHYSICIAN RECOMMENDED AN INCREASE TO THE DOSE OF THE PHENOBARBITAL THAT THE PATIENT WAS TAKING; HOWEVER, THE PATIENT DIDN¿T WANT THE INCREASE AS THE PHENOBARBITAL WOULD CAUSE SIDE-EFFECTS. IT WAS STATED THAT THE PATIENT WAS GETTING GOOD THERAPY FOR INDICATION OF RIGIDITY SECONDARY TO STIFF PERSON SYNDROME (SPS). ABOUT THREE MONTHS LATER, IT WAS REPORTED THAT THE PATIENT¿S WEIGHT WAS STABLE AND THE ISSUE WAS ENTIRELY RELATED TO THE PATIENT¿S UNDERLYING DISEASE AND ANXIETY. ONE YEAR LATER, IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING SYMPTOMS OF SIGNIFICANT ACUTE GENERALIZED PAIN, NAUSEA, DEPRESSION, INSOMNIA, THE INABILITY TO FEEL HUNGRY, AND THE INABILITY TO EAT SOLIDS AND LIQUIDS. ADDITIONALLY, IT WAS STATED THAT THE PATIENT HAD PLANTAR FLEXION IN HER FEET AND HANDS WHERE THEY WERE ¿TURNED UNDER¿. THE SPS HAD BEEN AFFECTING THE PATIENT FOR 14 YEARS AND HAD PROGRESSED INTO HER UPPER BODY, CHEST, AND THROAT AREA WHERE IT AFFECTED HER VOICE. THE PATIENT WAS REPORTEDLY ON NUMEROUS MEDICATIONS FOR HER DIFFERENT MEDICAL ISSUES, THOUGH SOME OF THEM WERE NO LONGER EFFECTIVE. THE DEVICE SYSTEM WAS USED TO DELIVER LIORESAL. TWELVE DAYS LATER, IT WAS REPORTED THAT THE EVENT WAS NOT RELATED TO THE INTRATHECAL BACLOFEN PUMP. ABOUT SEVEN MONTHS LATER, IT WAS REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED ON AND OFF FOR ¿NAUSEA AND SO FORTH FROM THE PUMP¿. DUE TO THE NAUSEA, THE PATIENT HAD BEEN ON JUST ENSURE LIQUIDS FOR TWO YEARS, BECAUSE OF THE PATIENT¿S INABILITY TO TOLERATE FOODS. DURING THE WEEK PRIOR TO REPORT, THE PATIENT WAS HOSPITALIZED BECAUSE, SHE APPEARED TO BE DEHYDRATED. ADDITIONALLY, A SCAN WAS PERFORMED TO CHECK FOR A BLOCKAGE, BUT THE PUMP HAD NOT BEEN CHECKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323637 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization