BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1061438 · Received June 17, 2008

    Report

    Report Number
    6000030-2008-03280
    Event Type
    Injury
    Date Received
    June 17, 2008
    Date of Event
    May 17, 2008
    Report Date
    May 18, 2008
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT'S PUMP WAS REFILLED AND REPROGRAMMED TO DELIVER A HIGHER DOSAGE OF DILAUDID. EIGHTEEN HOURS LATER THE PT BEGAN HAVING OVER DOSE SYMPTOMS (NOT SPECIFIED). SHE WAS ADMITTED TO THE INTENSIVE CARE UNIT, INTUBATED, AND GIVEN NARCAN. HER CONDITION WAS REPORTED AS SERIOUS. THE PUMP WAS REPROGRAMMED TO A STOPPED INFUSION MODE IN 2008. ADD'L INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AND IT WAS REPORTED THAT THE PUMP WAS REMOVED 5 YEARS AGO BECAUSE THE PUMP HAD ¿A MALFUNCTION¿. THE PATIENT WAS OVERDOSED AND IT ¿SHUT HER RESPIRATORY DOWN¿. THE PATIENT WAS IN A COMA FOR 8 DAYS. WHEN THEY REMOVED THE PUMP, THE PATIENT WAS PAIN FREE FOR SEVERAL YEARS. NO DOCTOR COULD EXPLAIN WHY SHE WAS PAIN FREE FOR SEVERAL YEARS. THE PATIENT¿S PAIN THEN RETURNED. SHE TRIED PATCHES/FENTANYL AND NOTHING HAD HELPED WITH HER PAIN, SO HER PHYSICIAN WAS ADVISING THAT SHE SHOULD HAVE ANOTHER PUMP IMPLANTED. THE FAMILY WAS LOOKING FOR A NEW PUMP PHYSICIAN AS THE PATIENT¿S PRIOR PHYSICIAN HAD RETIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK RICE CREEK MFG 8627L18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR Hospitalization| L| R IMPLANTED:| CATHETER MODEL 8709 LOT# J11401R08| PROGRAMMER 8840 LOT: UNK| EXPLANTED:| OXYCONTIN 80 MG TID