BEUDAMED
    FDA Adverse Event Death Summary report: N

    ICP SENSOR BOLT KIT

    MDR report key: 1731631 · Received June 19, 2010

    Report

    Report Number
    1226348-2010-00201
    Event Type
    Death
    Date Received
    June 19, 2010
    Date of Event
    June 15, 2010
    Manufacturer
    CODMAN & SHURTLEFF, INC., MEDOS S.A.
    Product Code
    GWM
    PMA / PMN Number
    K914479
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AFFILIATE EXPLAINED THAT THE PATIENT UNDERWENT SURGERY FOR AN ANEURYSM. ON THE FOURTH DAY, THE PATIENT'S CONDITION WORSENED WITH A VASOSPASM AND LOSS OF CONSCIOUSNESS. AS A RESULT, THE PATIENT WAS INTUBATED AND HAD A MICROSENSOR IMPLANTED. A TOMOGRAPHY WAS TAKEN TO ENSURE THE PLACE OF THE PROBE, AND IT WAS NOTED TO BE LOCATED IN THE BRAIN'S PARENCHYMA PROPERLY. THE PATIENT WAS SENT TO ANGIOGRAPHY AND IT WAS FOUND THAT A BRAIN VESSEL WAS EXPANDED. DURING THIS TIME, THE ICP MICROSENSOR WAS READING 5-6 MMHG, HOWEVER, THE CLINICAL SYMPTOMS OF THE PATIENT HAD WORSENED AND THE PATIENT SLIPPED INTO A COMA. THE MICROSENSOR WAS THEN REVISED AND THE NEW PRESSURE READING WAS 150MMHG. IT WAS EXPLAINED THAT WITH THE NEW PRESSURE READING, TIME DID NOT ALLOW FOR SURGERY, AND AS A RESULT THE PATIENT DIED. PLEASE SEE REPORT (B)(4) FOR DETAILS PERTAINING TO THE ICP EXPRESS MONITOR REPORTED WITH THE ICP SENSOR BOLT KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICP SENSOR BOLT KIT DEVICE, INTRACRANIAL PRESSURE MONITORING GWM CODMAN & SHURTLEFF, INC., MEDOS S.A. NA CLBCJF

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death