BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSAID IMPLANTABLE INFUSION PUMP

    MDR report key: 38892 · Received September 18, 1996

    Report

    Report Number
    1219454-1996-00412
    Event Type
    Injury
    Date Received
    September 18, 1996
    Date of Event
    August 20, 1996
    Report Date
    September 18, 1996
    Manufacturer
    STRATO/INFUSAID, INC.
    Product Code
    MDY
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON 10/1/96, THE PHYSICIAN REPORTED THAT THE PATIENT IS DOING WELL AND "EVERYTHING APPEARS TO BE FINE." THE DEVICE PORT HAS BEEN ACCESSED AND WAS FOUND TO BE PATENT AND THE DEVICE APPEARS TO BE FUNCTIONING AS INTENDED. THE PHYSICIAN ALSO STATED THAT THE DEVICE WILL NOT BE ACCESSED AGAIN FOR APPROXIMATELY ONE MONTH; HOWEVER, NO FURTHER DIFFICULTIES ARE BEING EXPERIENCED AT THIS TIME. THE DEVICE WILL REMAIN IMPLANTED FOR CONTINUED USE IN THE PATIENT'S THERAPY REGIMEN. A TREND ANALYSIS WAS PERFORMED ON SIMILAR REPORTS INVOLVING THIS PART NUMBER AND NO TRENDS HAVE BEEN IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, AND DUE TO UNAVAILABILITY OF THE DEVICE FOR ANALYSIS, NO CONCLUSION COULD BE DRAWN AS TO THE CAUSE OF THIS EVENT. NO FURTHER DETAILS ARE AVAILABLE. THE MFR IS NOW CLOSING ITS FILE ON THIS REPORT.

    Description of Event or Problem · 1

    THE DEVICE WAS IMPLANTED ON 8/12/96 FOR INTRATHECAL INFUSION OF MORPHINE FOR TREATMENT OF PAIN. ON 8/20/96, THE PHYSICIAN CONTACTED A MFR NURSE AND REPORTED THAT AT THE TIME OF IMPLANT, THE DEVICE WAS REFILLED WITH 24CC PRESERVATIVE FREE MORPHINE SULFATE (PFMS)-(0.2 MG/DAY). THE DEVICE WAS REFILLED ON 8/20/96; HOWEVER, ONLY 4CC HAD INFUSED. (RESIDUAL VOLUME 20CC). THE PHYSICIAN STATED THAT HE ATTEMPTED TO FLUSH THE DEVICE SIDEPORT, BUT WAS UNABLE TO ACCESS IT. THE PHYSICIAN ALSO STATED THAT HE WAS IN ER AT THE TIME AND THE CONDITIONS WERE NOT IDEAL TO TRY MORE THAN ONCE. THE DEVICE WAS THEN REFILLED WITH 50CC PFMS 0.4MG/DAY. THE PT HAS REPORTED A DEFINITE IMPROVEMENT. THE PHYSICIAN STATED THAT HE WILL MONITOR THE PT OVER THE NEXT WEEK AND IF IMPROVEMENT CONTINUES, HE WILL REFILL THE DEVICE AT THE EXPECTED INTERVAL; IF NOT, HE WILL BRING THE PT BACK AND DO A SIDEPORT STUDY UNDER FLUOROSCOPY TO CHECK PATENCY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention