BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSAID IMPLANTABLE INFUSION PUMP

    MDR report key: 106354 · Received July 17, 1997

    Report

    Report Number
    1219454-1997-00262
    Event Type
    Injury
    Date Received
    July 17, 1997
    Date of Event
    June 5, 1997
    Report Date
    June 18, 1997
    Manufacturer
    STRATO/INFUSAID, INC.
    Product Code
    LKK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN'S OFFICE WAS CONTACTED FOR FURTHER INFO ON THIS EVENT, HOWEVER, CO'S ATTEMPTS HAVE BEEN UNSUCCESSFUL. SINCE THE MFR HAS NOT RECEIVED ANY ADDITIONAL INFO ON THIS EVENT, CO'S INVESTIGATION OF THIS EVENT WAS LIMITED TO A REVIEW OF THE DEVICE HISTORY RECORD AND A TREND ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED AND DID NOT IDENTIFY ANY MFG VARIANCES IN RELATION TO THIS EVENT. A TREND ANALYSIS WAS PERFORMED ON SIMILAR INCIDENTS INVOLVING THIS CAT. NUMBER AND HAS NOT IDENTIFIED ANY TRENDS. THE MFR'S INVESTIGATION OF THIS EVENT IS INCONCLUSIVE. BASED ON THE INFO AVAILABLE NO CONCLUSION CAN BE DRAWN AS TO THE CAUSE OF THIS EVENT. THE FACILITY WILL BE NOTIFIED OF OUR REVIEW OF THIS EVENT. NO FURTHER INFO IS AVAILABLE. THE MFR IS NOW CLOSING IT'S FILE ON THIS EVENT.

    Description of Event or Problem · 1

    ON 06/18/97, THE FACILITY NURSE CONTACTED A MANUFACTURER CLINICAL REPRESENTATIVE AND REPORTED A DEVICE SLOW FLOW. THE DEVICE WAS IMPLANTED ON 04/04/1995 FOR INTRATHECAL INFUSION OF MORPHINE FOR TREATMENT OF PAIN. THE CALIBRATED DEVICE FLOW RATE IS .97, ACTUAL FLOW RATE HAS BEEN .78 TO .8. ON 06/05/1997, THE PATIENT WAS IN FOR EVALUATION FOR COMPLAINTS OF PAIN. A DYE STUDY WAS PERFORMED WHICH ILLUSTRATED THE DEVICE CATHETER DELIVERING TO THE INTRATHECAL SPACE WITH NO LEAKS. THE DEVICE WAS REFILLED WITH INCREASED CONCENTRATION OF DRUG. THE PATIENT CALLED IN A DAY OR SO LATER STATING THAT SHE FELT "FUNNY", SEDATED, AND HAD TROUBLE BREATHING. SINCE THE PATIENT HAS RESPIRATORY PROBLEMS, THE NURSE ASSURED THE PATIENT THAT THIS WAS NORMAL AND WOULD PASS. TODAY (06/18/1997) 13 DAYS LATER, THE PATIENT IS IN FOR A DEVICE REFILL. THE RESIDUAL VOLUME IS 17ML, INFUSED VOLUME 23 , FLOW RATE 1.769ML/DAY. THE PATIENT STATED THAT WITHIN 24 HOURS OF THE DEVICE REFILL, SHE HAD CONTINUOUS PAIN. THE FACILITY NURSE STATED THAT SHE FOLLOWS PROCEDURE OF 5CC IN AND 1CC BACK DURING THE DEVICE REFILL, AND THERE WAS AND IS NO EVIDENCE OF FLUID IN THE DEVICE POCKET. THE MANUFACTURER CLINICAL REPRESENTATIVE RECOMMENDED FILLING THE DEVICE WITH PRESERVATIVE FREE SALINE AND BRINGING THE PATIENT BACK IN ONE WEEK TO SEE WHAT HAPPENS. THE FACILTY NURSE WILL CALL WITH THE DEVICE FLOW RATE IN ONE WEEK (06/25/1997).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSAID IMPLANTABLE INFUSION PUMP Implant IMPLANTABLE INFUSION PUMP LKK STRATO/INFUSAID, INC. 400 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention