BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSAID IMPLANTABLE INFUSION PUMP

    MDR report key: 102982 · Received July 3, 1997

    Report

    Report Number
    1219454-1997-00283
    Event Type
    Injury
    Date Received
    July 3, 1997
    Date of Event
    June 5, 1997
    Report Date
    June 6, 1997
    Manufacturer
    STRATO/INFUSAID, INC.
    Product Code
    LKK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MFR AND HAS BEEN ANALYZED AS FOLLOWS: NUMEROUS NEEDLE MARKS, RAISED TEARS AND MISSING SILICONE CHUNKS WERE SEEN ON THE DEVICE CENTER SEPTUM; HOWEVER, NO INTERNAL DAMAGE WAS NOTED ON THE DEVICE CENTER OR SIDEPORT SEPTA. THE DEVICE FLOWED WITHIN ORIGINAL MFR FLOW RATE SPECIFICATIONS AS RECEIVED. LEAK TESTING OF THE DEVICE REVEALED THAT THE DEVICE CENTER SEPTUM LEAKED FROM THE SEPTUM PERIPHERY WHEN INTRODUCING 30PSI AIR. NO OTHER LEAKS OR ANOMALIES WERE SEEN. A TREND ANALYSIS WAS PERFORMED ON SIMILAR INCIDENTS FOR THIS CAT NUMBER AND A TREND WAS NOT IDENTIFIED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED THAT THIS DEVICE WAS PART OF THE MFR'S DECEMBER 13, 1991 DEVICE RECALL FOR THE POTENTIAL OF LEAKAGE OF THE DEVICE SEPTUM. NO OTHER MFG VARIANCES RELATED TO THIS EVENT WERE NOTED. BASEDON THE INFO AVAILABLE AND THE RESULTS OF THE MFR'S ANALYSIS OF THE DEVICE, THE REPORT OF "LEAKAGE FROM THE DEVICE CENTER SEPTUM" HAS BEEN CONFIRMED. CORRECTIVE ACTION WAS IMPLEMENTED VIA THE DECEMBER 1, 1991 DEVICE RECALL. NO FURTHER DETAILS ARE AVAILABLE. THE CUSTOMER WILL BE NOTIFIED OF THE MFR'S FINDINGS. THE MFR IS NOW CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE DEVICE WAS IMPLANTED ON 05/09/1991, FOR INTRATHECAL INFUSION OF MORPHINE FOR TREATMENT OF PAIN (NOTE: INTRATHECAL INFUSION OF MORPHIN EWAS NOT THE MANUFACTURER'S (MFR) INDICATION FOR THE DEVICE'S INTENDED USE). ON 06/06/97, THE PHYSICIAN CONTACTED THE MFR'S CLINICAL REPRESENTATIVE TO REPORT THAT THE DEVICE HAS A TWENTY-ONE (21) DAY REFILL PERIOD WITH AN ACTUAL FLOW RATE OF 1.6ML/DAY. THE DEVICE WAS EMPTIED 06/05/1997, WITH NO RESIDUAL VOLUME RECEIVED. THE PHYSICIAN IS EXPERIENCED WITH ANOTHER MFR'S DEVICE AND USES THE OTHER MFR'S NEEDLES TO ACCESS THIS DEVICE AND WAS QUESTIONING THE INTEGRITY OF THE DEVICE SEPTUM USING ANOTHER MFR'S NEEDLES AND OTHER POSSIBLE CAUSES OF THE DEVICE BEING EMPTY. THE PHYSICIAN WANTED TO ACCESS THE DEVICE THE FOLLOWING MONDAY (06/09/1997) TO CHECK THE DEVICE CENTER RESERVOIR AND SIDEPORT PATENCY AND WOULD LIKE A MFR NURSE ON STANDBY. AT THAT TIME, THE PHYSICIAN WOULD DETERMINE IF A DYE STUDY WAS NECESSARY AFTER CHECKING THE DEVICE SIDEPORT ON 06/09/1997. THE MFR'S CLINICAL REPRESENTATIVE HAD TWO (2) OF THE MFR'S REFILL KITS AND THE DEVICE CLINICIAN'S MANUAL SENT TO THE PHYSICIAN FOR NEXT DAY DELIVERY. NO FURTHER DETAILS WERE PROVIDED AT THIS TIME.

    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