BEUDAMED
    FDA Adverse Event Death Summary report: N

    INDURA

    MDR report key: 1052409 · Received May 27, 2008

    Report

    Report Number
    6000030-2008-02827
    Event Type
    Death
    Date Received
    May 27, 2008
    Report Date
    April 25, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS REVEALED A PUMP CONNECTOR ANOMALY. AN INDENT THE SHAPE AND DIAMETER OF AN OUTLET PORT OF A PUMP COULD BE SEEN ON THE SEAL MATERIAL INSIDE THE CUP OF THE CONNECTOR. THIS INDICATED THE CONNECTOR WAS MOSTLY LIKELY INCORRECTLY INSERTED ONTO THE OUTLET PORT OF THE PUMP IN SUCH A WAY, IT CAUSED OCCLUSION OF THE SUTURELESS CONNECTOR AND THEN DAMAGE TO THE MATERIAL OF THE CONNECTOR.

    Description of Event or Problem · 1

    DURING PUMP REPLACEMENT SURGERY, THE HCP WAS UNABLE TO ASPIRATE, BUT WHEN THE HCP TOOK OFF THE CATHETER, HE HAD FREE FLOW OF CSF SO HE DID NOT THINK THERE WAS ANYTHING WRONG WITH THE CATHETER AND DECIDED TO REPLACE THE PUMP. THE PT'S PUMP WAS REPLACED; THE DAILY DOSAGE WAS DECREASED FROM 8 MG TO 2 MG/DAY OF MORPHINE. THE PT ALSO USED ORAL MORPHINE TO CONTROL HER PAIN. ONE DAY AFTER IMPLANT, THE PT WAS FOUND UNRESPONSIVE. EMERGENCY MEDICAL SERVICES WAS CALLED AND CARDIOPULMONARY RESUSCITATION WAS UNSUCCESSFULLY PERFORMED. THE CAUSE OF DEATH WAS REPORTED AS ARTERIOSCLEROTIC HEART DISEASE. THE DEATH WAS NOT CONSIDERED DEVICE-RELATED AND NO AUTOPSY WAS BEING PERFORMED AS MD DID NOT FEEL IT WAS A SUSPICIOUS DEATH. THE PUMP WAS RETURNED FOR ANALYSIS (PLEASE SEE MFG. REPORT # 2182207200801815). A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INDURA LKK RICE CREEK MANUFACTURING 8709SC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death IMPLANTED:| PUMP MODEL # 863720| PROGRAMMER MODEL 8840 LOT# UNK| EXPLANTED: