BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1800535 · Received August 12, 2010

    Report

    Report Number
    6000030-2010-06088
    Event Type
    Injury
    Date Received
    August 12, 2010
    Date of Event
    January 1, 2008
    Report Date
    July 15, 2010
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED THE RETURN OF PAIN IN THE LAST "COUPLE YEARS". THE PAIN WAS STATED AS BEING "REAL BAD" FOR THE PREVIOUS SIX MONTHS. THE PATIENT STATED THAT THERE WAS "FEVER" AT THE PUMP SITE AND SORENESS AROUND THE SITE. THE PATIENT ALSO REPORTED A DECREASE IN EATING AND A FEVER. THE FAMILY PHYSICIAN SUGGESTED THAT THESE SYMPTOMS WERE LINKED TO THE PATIENT'S PUMP. THE PATIENT'S HEALTH CARE PROVIDER (HCP) HAD "TROUBLE" GETTING A NEEDLE INTO THE PUMP DURING REFILL PROCEDURES. IT WAS SUGGESTED THAT THE PUMP HAD FLIPPED. THERE WERE NO PUMP ALARMS. IT WAS FURTHER REPORTED THAT THE PATIENT HAD WITHDRAWAL-LIKE SYMPTOMS. IT WAS DESCRIBED THAT THE PATIENT WAS "FINE" ONE DAY BUT THE NEXT DAY EXPERIENCED SHAKING AND WAS UNABLE TO "REMEMBER WHAT HAPPENED". THE PATIENT REPORTED RUNNING LOW GRADE FEVERS IN BETWEEN EPISODES OF "HIGH FEVER". THE PATIENT'S HCP RECOMMENDED THAT THE PATIENT BE SEEN IN THE EMERGENCY ROOM. IT WAS FURTHER REPORTED THAT THE PATIENT WAS RELEASED FROM THE HOSPITAL AFTER BEING ADMITTED FOR SEVERE PAIN, SHAKING, AND FEVER. THE PATIENT'S PUMP CONTAINED DILAUDID AND WAS REFILLED AROUND THE END OF (B)(6)2010. AT THAT TIME, THE PATIENT'S HCP CHECKED THE PUMP AND FELT THERE WAS NO ISSUE WITH THE PUMP. THE PATIENT WAS GIVEN TWO ANTIBIOTICS FOR INFECTION AT THE HOSPITAL. THE PATIENT WAS "A LITTLE BETTER" UPON RETURNING FROM THE HOSPITAL, BUT WAS STILL IN PAIN AND HAD FEVERS AND SHAKING ON OCCASION. 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 EL LKK RICE CREEK MANUFACTURING 8627L18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Hospitalization| R CATHETER: MODEL 8703W, LOT# L47177| EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8703W, LOT# L47177| IMPLANTED:| EXPLANTED: