BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3203517 · Received July 3, 2013

    Report

    Report Number
    3004209178-2013-04448
    Event Type
    Injury
    Date Received
    July 3, 2013
    Report Date
    August 30, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS DISSATISFIED WITH HIS HEALTH CARE PROFESSIONAL SERVICE. IN 2010, THE DOCTOR HAD DECREASED THE PATIENT¿S PUMP DOSAGE. THE DOCTOR REFUSED TO INCREASE THE DOSAGE BECAUSE THE PATIENT ¿WOULD STOP BREATHING.¿ THE PUMP WAS USED TO DELIVER MORPHINE, AND THEN THE DOCTOR CHANGED THE DRUG TO DILAUDID. DURING PATIENT¿S REFILL SESSIONS, THE DOCTOR DID NOT REMOVE ANY MEDICATION FROM THE PUMP. THE LAST REFILL SESSION DID NOT TAKE AS LONG AS PREVIOUS REFILLS. A DOCTOR FROM VETERAN MEDICAL CENTER WAS CONCERNED OF THE PATIENT¿S HIGH BLOOD SUGAR. THE DOCTOR SUSPECTED THAT THE HIGH BLOOD SUGAR WAS DUE TO STRESS ASSOCIATED WITH PAIN, BUT THE PATIENT WAS INFORMED BY HIS PAIN DOCTOR THAT THE CAUSE OF HIS HIGH BLOOD SUGAR WAS NOT DUE TO PAIN. THE PATIENT ALSO HAD HIGH BLOOD PRESSURE AND DIABETES. IT WAS NOTED THAT THE PATIENT HAD SWELLING IN HIS LEG AND SORENESS UNDERNEATH THE PUMP. THE PATIENT SUSPECTED THAT THE SURGEON HAD ¿PUT THE PUMP IN UPSIDE DOWN OR WRONG.¿ THE PATIENT WOULD LIKE THE HAVE THE PUMP EXPLANTED BECAUSE HE W AS ¿DOUBLED OVER IN PAIN.¿ THE PATIENT WOULD BE IN PAIN WHEN HE WOKE UP IN THE MORNINGS. HE COULD NOT SLEEP IN A BED BECAUSE HE COULD NOT GET COMFORTABLE DUE TO THE PAIN. THE PUMP ¿WAS NOT HELPING HIM¿ AND HE WOULD HAVE TEARS COMING DOWN HIS FACE BECAUSE HE WAS IN SO MUCH PAIN. THE PATIENT HAD BEEN ¿SUFFERING WITH THIS FOR 43 YEARS FOR EVERYDAY OF HIS LIFE.¿ HE THOUGHT OF ¿JUST GOING TO TAKE A BRIDGE.¿ THE DEVICE SYSTEM WAS USED TO DELIVER DILAUDID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303799 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Other