BEUDAMED
    FDA Adverse Event Death Summary report: N

    EDM LUMBAR DRAINAGE KIT, OPEN TIP CATHETER

    MDR report key: 3833973 · Received May 27, 2014

    Report

    Report Number
    2021898-2014-00176
    Event Type
    Death
    Date Received
    May 27, 2014
    Date of Event
    February 18, 2014
    Report Date
    April 28, 2014
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    GWM
    PMA / PMN Number
    K802100
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS UNAVAILABLE FOR RETURN. THEREFORE AN EVALUATION OF DEVICE PERFORMANCE WAS NOT POSSIBLE. INFORMATION REGARDING THE EXACT DATE OF PATIENT DEATH IS UNKNOWN. A REVIEW OF THE MANUFACTURING AND STERILIZATION RECORDS SHOWED NO ANOMALIES. ADDITIONAL DEVICE/PATIENT INFORMATION: IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT PATIENT HAD GONE TO THE HOSPITAL DUE TO CEREBRAL ANEURYSM. ACCORDING TO THE REPORT, THE PHYSICIAN PERFORMED THE SURGERY AND PATIENT STATUS WAS GOOD. THE REPORT STATED THAT THE DOCTOR IMPLANTED THE PRODUCT AFTER THE SURGERY FOR THE CEREBRAL ANEURYSM. REPORTEDLY, THE CEREBROSPINAL FLUID WAS CLEAR DURING THE SURGERY. ACCORDING TO THE REPORT, ONE DAY AFTER IMPLANTATION, THE PATIENT GOT A FEVER AND IT WAS FOUND THAT THE CEREBROSPINAL FLUID TURNED PURULENT. THE REPORT STATED THAT, PER THE LAB TEST RESULTS, THE PROTEIN COUNT OF THE CEREBROSPINAL FLUID WAS VERY HIGH AND REACHED MORE THAN 20000 UNITS. (B)(4).

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE PATIENT HAD A CEREBROSPINAL FLUID INFECTION AFTER IMPLANTATION OF THE DEVICE. ACCORDING TO THE REPORT, THE PATIENT¿S WBC COUNT WAS FOUND TO HAVE INCREASED. THE REPORT STATED THAT THE DOCTOR EXPLANTED THE PRODUCT AND TREATED THE PATIENT WITH AN ANTIBIOTIC. REPORTEDLY, THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311372 EDM LUMBAR DRAINAGE KIT, OPEN TIP CATHETER DEVICE, MONITORING, INTRACRANIAL PRESSURE GWM MEDTRONIC NEUROSURGERY 207441165

    Patients

    Seq Age Sex Outcome Treatment
    1 Death