BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1830824 · Received September 8, 2010

    Report

    Report Number
    3004209178-2010-06870
    Event Type
    Injury
    Date Received
    September 8, 2010
    Date of Event
    August 12, 2010
    Report Date
    August 17, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO DAYS AFTER DEVICE IMPLANTATION, THE PATIENT'S TONE WAS "MARKEDLY IMPROVED." THE PATIENT WAS ALSO ABLE TO SLOWLY LOWER THE LEFT HAND AND FOREARM IN FULL SUPINATION. THE PATIENT BEGAN TO EXPERIENCE DIARRHEA. IT WAS NOT POSSIBLE FOR THE PATIENT TO ACHIEVE A SITTING POSITION IN BED. THE PATIENT EXPERIENCED PAIN AFTER BEING TRANSFERRED TO A WHEELCHAIR IN A FULLY RECLINED POSITION. THE PATIENT BEGAN "LIP SMACKING," WHICH BECAME "CONTINUOUS" BY THE EVENING OF (B)(6) 2010. IT WAS SUGGESTED THAT A NEUROLOGY CONSULTATION WAS NECESSARY. AN OVERNIGHT EEG WAS PERFORMED THE FOLLOWING DAY. IT WAS ALSO NOTED THAT THERE WAS BLOOD IN THE "EXTENDER TUBE AND WASHCLOTH UPON VENTING." IT WAS FURTHER REPORTED THAT THE PATIENT (APPROXIMATELY ONE WEEK POST-OPERATIVE) WAS "NOT DOING WELL." THE PATIENT WAS NOT ABLE OR WILLING TO EAT ORALLY; SHOWED OBVIOUS SIGNS OF DISCOMFORT DURING TUBE FEEDINGS; APPEARED TO BE IN PAIN; HAD NAUSEA AND DIARRHEA; AND COULD NOT TOLERATE ANY POSITION OTHER THAN SUPINE WITHOUT DISTRESS AND PAIN. THE PATIENT WAS REPORTED TO BE "QUITE SAD AND DEPRESSED." ON (B)(6) 2010, THE PATIENT HAD A GENERALIZED TONIC CLONIC SEIZURE. THE PATIENT HAD BEEN GIVEN DIAZEPAM EARLIER IN THE DAY FOR THE LIP SMACKING, PAIN MANAGEMENT, AND SLEEP. IT WAS NOTED THAT THE LIORESAL CONCENTRATION IN THE PATIENT'S PUMP WAS 500 MCG/ML AND THE DOSAGE WAS 100 MCG/DAY. NO FURTHER DETAILS OR PATIENT OUTCOME WERE PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Required Intervention IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709SC, LOT # N258689010