BEUDAMED
    FDA Adverse Event Death Summary report: N

    COMPLETE BRAIN IMC-PROBE KIT:MSR O2 AND TEMP CC1.SB C8.B IM3 STERILE

    MDR report key: 5095673 · Received September 22, 2015

    Report

    Report Number
    9617494-2015-00022
    Event Type
    Death
    Date Received
    September 22, 2015
    Date of Event
    August 30, 2015
    Report Date
    September 2, 2015
    Manufacturer
    GMS
    Product Code
    GWM
    PMA / PMN Number
    K002765
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE PHYSICIAN ON (B)(6) 2015: THE DIAGNOSIS OF THE PATIENT ON ADMISSION AND DISCHARGE WERE TBI, MULTIPLE TRAUMATIC CONTUSIONS, DIFFUSE AXONAL INJURY. THE LICOX WAS IMPLANTED FOR INTRACRANIAL (ICP) MONITORING FOLLOWING SEVERE TRAUMATIC BRAIN INJURY (TBI). THE CLINICIAN HAS REMOVED LICOX PROBES BEFORE. THE CLINICIAN DID NOT ENCOUNTER ANY COMPLICATIONS DURING EXTRACTION OF THE LICOX PROBE. THE ATTENDING CLINICIAN STATED THAT THE BLEEDING OCCURRED MANY DAYS AWAY FROM THE INITIAL INJURY; BELIEVED THE HEMORRHAGE WAS EXACTLY AT THE LICOX LOCATION, COULD NOT RULE OUT HEMORRHAGE INTO CONTUSION. THE PATIENT HAD AN INTRACEREBRAL HEMATOMA (SIZE: 4,5 X 2,7 X 4.0 = 24,3CC). THE HEMATOMA DID NOT REQUIRE SURGICAL TREATMENT (E.G. CRANIOTOMY). THE PATIENT¿S OPERATIVE PROCEDURE NOTE AS WELL AS CT SCANS ON ADMISSION, ICU COURSE, POST ICU COURSE, RECOVERY AND DISCHARGE WERE REQUESTED BUT NOT PROVIDED. THE DECISION WAS MADE NOT TO INTERVENE (MEANING RESECTION/EVACUATING THE HEMATOMA) AFTER THE BLEED BECAUSE THE PATIENT HAD A POOR EXAM, NO TERRIBLE MIDLINE SHIFT. THE CIRCUMSTANCES SURROUNDING THE PATIENT¿S DEATH WAS REPORTED AS: THE PATIENT WAS ADMITTED AFTER A FALL. COMATOSE AT PRESENTATION. NO IMPROVEMENT IN CLINICAL EXAM. FAMILY MEETING AND DECISION TO MOVE TO COMFORT MEASURES. THE CAUSE OF DEATH WAS REPORTED AS TRAUMATIC BRAIN INJURY. NO AUTOPSY WAS PERFORMED.

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 01/19/2016 . THE INVESTIGATION INCLUDED: RESULTS: DOCUMENTATION OF ALL POSSIBLE BATCHES ((B)(4) BATCHES) HAVE BEEN REVIEWED. NO ANOMALITIES HAVE BEEN REPORTED. NO NCR OR ANY VARIANCES WERE ASSOCIATED WITH THESE LOTS. THE LOTS MET THE SPECIFICATION AT THE TIME OF RELEASE. CONCLUSION: COMPLAINT RELATED DEVICE WAS NOT RETURNED, NO MORE DETAILED INFORMATION ABOUT THE COMPLAINT AVAILABLE. SO TREND ANALYSIS AND ROOT CAUSE ANALYSIS COULDN'T BE PERFORMED PROPERLY.

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED A COMPLICATION POST REMOVAL OF A LICOX BOLT. THE PATIENT DEVELOPED A LARGE CEREBRAL BLEED RIGHT AT THE INSERTION PLACEMENT SITE. THE LICOX CATHETER WAS INSITU FOR 5 DAYS. POST INSERTION CT OF THE HEAD WAS COMPLETED WITHOUT A BLEED. ADDITIONAL INFORMATION WAS REQUESTED AND ON (B)(6) 2015, THE FOLLOWING WAS RECEIVED: A (B)(6) FEMALE PATIENT HAD THE LICOX BOLT IMPLANTED TO THE RIGHT ANTERIOR FRONTAL SCALP AREA ON (B)(6) 2015 AT 1238HRS. ON (B)(6) 2015 AT 1042HRS, IT WAS REMOVED BY THE NEUROSURGICAL RESIDENT AS PER USUAL PROCESS. NOTHING WAS REPORTED OR OBSERVED DURING THE REMOVAL. APPROXIMATELY 2 HOURS HAD ELAPSED BETWEEN REMOVAL OF THE SYSTEM AND THE DEVELOPMENT OF THE BLEEDING. THE PATIENT WAS NOT STARTED ON ANY ANTICOAGULANTS SUCH AS ASPIRIN OR HEPARIN DURING HER STAY IN THE INTENSIVE CARE UNIT (ICU). NO ACTION/TREATMENT WAS TAKEN FOR THE CEREBRAL BLEED. THE PATIENT WAS CONTINUED TO BE MONITORED. PATIENT OUTCOME WAS REPORTED AS PATIENT DIED ON (B)(6) 2015 AT 1502HRS. ADDITIONAL INFORMATION REGARDING THE DETAILS OF THE PATIENT'S DEATH HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625711 COMPLETE BRAIN IMC-PROBE KIT:MSR O2 AND TEMP CC1.SB C8.B IM3 STERILE LICOX BOLTS CATHETERS & KITS GWM GMS

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death| O