BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3240194 · Received July 22, 2013

    Report

    Report Number
    3004209178-2013-12072
    Event Type
    Injury
    Date Received
    July 22, 2013
    Report Date
    July 2, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8703W, LOT # L52363, IMPLANTED: (B)(6) 1998, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD AN INFECTION. IT WAS STATED THE PUMP FUNCTIONED ¿PERFECTLY¿ FOR THE FIRST TWO MONTHS. THEN THE PATIENT¿S SKIN STARTED TURNING PINK AT THE PUMP SITE AND HE OVERHEARD THE HEALTH CARE PROVIDER TALKING ABOUT AN INFECTION. THE PATIENT SAID THE INFECTION WAS NEVER CONFIRMED. THE PATIENT WAS HOSPITALIZED ONE WEEK PRIOR TO THIS REPORT DATE, DUE TO HIS ¿NERVES." THE PATIENT STATED THEY DECREASED HIS DOSAGE THREE TIMES AND THEN PLACED HIM ON A MORPHINE PATCH. THE PATIENT STATED THIS WAS TOO STRONG, AND HE WAS ¿OUT OF IT.¿ THE MORPHINE PATCH WAS REPLACED WITH A LOWER DOSAGE; HOWEVER THE PATIENT STATED IT WAS STILL TOO STRONG AND CONTINUED TO FEEL ¿OUT OF IT.¿ THE MORPHINE PATCH WAS TAKEN OFF ON (B)(6) 2013, AND ANOTHER ONE WAS PLACED THE FOLLOWING DAY. THE PATIENT REPORTED HE WAS UNABLE TO SLEEP THE NIGHT PRIOR TO THIS REPORT DATE BECAUSE HE WAS IN PAIN. HE TOOK TYLENOL TO HELP WITH THE PAIN, BUT IT DIDN¿T GIVE HIM PAIN RELIEF. THE PATIENT STATED THE PUMP WAS NOT YET INCREASED, AND THAT HE WANTED IT REFILLED. THE PATIENT WAS GOING TO FOLLOW UP WITH HIS HEALTH CARE PROVIDER NEXT ON (B)(6) 2013. THE PUMP MEDICATION WAS UNKNOWN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEVICE SYSTEM WAS USED TO INFUSE MORPHINE. IT WAS NOTED THAT THE EVENT WAS RELATED TO DURAGESIC PATCH APPLICATION/ INTOLERANCE, NOT DUE TO THE PUMP.¿ SYMPTOMS RELATED TO THE EVENT WERE NOTED AS DIZZINESS, NAUSEA AND VOMITING. THE PATIENT REQUIRED HOSPITALIZATION AS A RESULT OF THE EVENT. OUTCOME WAS REPORTED AS NON-SERIOUS INJURY-ILLNESS. IT WAS FURTHER REPORTED THAT THE ¿PATIENT WAS WEANED FROM INTRATHECAL PUMP MEDS, WAS GIVEN DURAGESIC FOR PAIN CONTROL, COULD NOT TOLERATE DURAGESIC PATCH, PUMP HAD NO FILL IN, SIDE EFFECT FROM DURAGESIC.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339520 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR Hospitalization| R