BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3243435 · Received July 23, 2013

    Report

    Report Number
    3004209178-2013-12193
    Event Type
    Injury
    Date Received
    July 23, 2013
    Report Date
    June 29, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8780 LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), PRODUCT TYPE CATHETER. (B)(4) .

    Description of Event or Problem · 1

    THE PATIENT¿S SISTER REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED DUE TO RESPIRATORY FAILURE OR RESPIRATORY ISSUES A COUPLE OF TIMES. THEY STATED, THE PATIENT WAS NOT GETTING THE CO2 OUT TO GET ENOUGH OXYGEN IN. THE PATIENT EVENTUALLY STABLED OUT, AND THEIR HEALTHCARE PROVIDER SENDS THEM HOME TELLING THE PATIENT ¿THEY DID NOT KNOW WHY AND WHAT WAS WRONG¿. THE PATIENT WAS NOTED TO HAVE RECENTLY BEEN REFILLED AND ¿SHE WAS GOOD¿. THEN SHE ¿STARTED HAVING SIGNS OF NARCOLEPSY¿ AND ¿FALLING ASLEEP AT THE DROP OF A HAT¿. THIS WAS CONFIRMED TO HAVE OCCURRED JUST AFTER THE MOST RECENT REFILL. THE PATIENT¿S LAST REFILL WAS ON (B)(6) 2013. THE PATIENT¿S DOSAGE WAS NOTED TO HAVE BEEN STEADILY INCREASED, AND THE PATIENT HAD BEEN DECREASING THE ORAL FORM. SYMPTOMS OF OVERDOSE INCLUDING DIZZINESS, SOMNOLENCE, DROWSINESS, LIGHT-HEADEDNESS, RESPIRATORY DEPRESSION, HYPOTHERMIA, AND LOSS OF CONSCIOUSNESS PROGRESSING INTO COMA WERE CONFIRMED BY THE PATIENT¿S SISTER. THE SISTER NOTED THAT THE LAST TIME THE PATIENT WENT 64) 2013. THE MEDICATION USED WITHIN THE SYSTEM WAS BACLOFEN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEVICE SYSTEM WAS USED TO INFUSE GABLOFEN. THE CAUSE OF THE EVENT WAS UNKNOWN. IT WAS NOTED THAT THE PATIENT WAS A CERVICAL SCI (SPINAL CORD INJURY) PATIENT WITH OCCASIONAL RESPIRATORY DEPRESSION- POSSIBLE SLEEP APNEA. PATIENT OUTCOME NOTED AS NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343789 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR Hospitalization