BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3201391 · Received July 2, 2013

    Report

    Report Number
    3004209178-2012-12178
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    February 9, 2012
    Report Date
    February 13, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8731 LOT# B005593N67, IMPLANTED: 2003 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELL ASLEEP THE NIGHT OF 201 (B)(6) WITH A HEATING PAD COVERING THEIR STOMACH AND UPPER BODY. WHEN THE PATIENT WOKE UP THEY WERE IN PAIN FROM THE CHEST DOWN TO THEIR TOES. THE PATIENT WAS DOUBLED OVER, LIKE THEY WERE CRAMPED. THE PATIENT IMMEDIATELY WENT TO THE HOSPITAL AND WAS THERE FOR 3 DAYS. THE PATIENT BEGAN HAVING CHEST PAINS IN THE HOSPITAL AND THE DOCTORS RAN TESTS ON THE PATIENT¿S HEART, BLOOD, AND URINE. IT WAS REPORTED THAT THE HOSPITAL ¿DID NOT KNOW MUCH ABOUT THE PUMP.¿ THE PATIENT WAS STILL HAVING ¿A LITTLE BIT OF SYMPTOMS¿ AFTER LEAVING THE HOSPITAL. THE DEVICE SYSTEM WAS USED TO DELIVER DILAUDID. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301706 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Hospitalization