BEUDAMED
    FDA Adverse Event Death Summary report: N

    CRANIAL PASSIVE INSTRUMENT SET

    MDR report key: 3325034 · Received September 4, 2013

    Report

    Report Number
    1723170-2013-00675
    Event Type
    Death
    Date Received
    September 4, 2013
    Date of Event
    May 24, 2013
    Report Date
    August 28, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K954276
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: THE (B)(6) 2013 DATE LISTED FOR THE 2ND SUBSEQUENT SURGERY ON THE INITIAL 3500A FORM 1723170-2013-00675 WAS INCORRECT. THE CORRECT DATE IS (B)(6) 2013. ADDITIONAL INFORMATION: THE FOLLOWING ADDITIONAL EVENT DESCRIPTION WAS RECEIVED ON 09/05/2013 BY A MEDTRONIC NAVIGATION, INC., REPRESENTATIVE: ONE OF THE HOSPITALS INVOLVED INFORMED US OF TWO ADDITIONAL PROCEDURES WHERE THE SAME FEE-PER-USE (FPU) CRANIAL PASSIVE INSTRUMENT SET WAS USED ON TWO PATIENTS. OUR REPRESENTATIVE WAS NOT PRESENT DURING THESE PROCEDURES; THEREFORE, MEDTRONIC NAVIGATION, INC. HAD NO RECORD OF THESE EVENTS AT THE TIME THE INITIAL MDR WAS SUBMITTED. THE REPORT WAS CONFIRMED BY SPEAKING TO ONE OF THE NEUROSURGEONS AT THE SITE, WHO EXPLAINED THAT TWO CERVICAL PROCEDURES WERE PERFORMED DURING THE MONTH OF (B)(6) (EXACT DATES UNCONFIRMED), 2013. THE SURGERIES WERE SUCCESSFUL WITH NO COMPLICATIONS REPORTED. THE SURGEON DECLINED TO PROVIDE PATIENT DEMOGRAPHIC INFORMATION. BOTH PATIENTS WERE NOTIFIED OF THEIR POSSIBLE EXPOSURE ON (B)(6) 2013 BY THE HOSPITAL.

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER AND PATIENT WEIGHT WERE UNAVAILABLE FROM THE SITE. A PATIENT AUTOPSY WAS PERFORMED AND AN INITIAL TEST INDICATED THE PRESENCE OF CJD PRIONS. THIS INITIAL TEST WILL BE FOLLOWED UP WITH A FINAL PATHOLOGY CONFIRMATION TEST, WHICH WILL TAKE SEVERAL WEEKS. MEDTRONIC NAVIGATION, INC. WILL FILE SUPPLEMENTAL MDRS TO REPORT ANY NEW INFORMATION. DATE OF DEATH IS REPORTED TO BE ON, OR AROUND, (B)(6) 2013. DEVICE LOT NUMBER, OR SERIAL NUMBER, NOT AVAILABLE AS PRODUCT HAS BEEN QUARANTINED. NO DEVICE AVAILABILITY AS THE CRANIAL PASSIVE INSTRUMENT SET IS IN QUARANTINE AT MEDTRONIC NAVIGATION, INC. THERE HAS BEEN NO CONFIRMATION OF INSTRUMENT SET CONTAMINATION. NO ALLEGATIONS WERE MADE OF MEDTRONIC NAVIGATION'S DEVICE CAUSING OR CONTRIBUTING TO THE PATIENT EVENT. THE INSTRUMENT SET IS IN QUARANTINE AND NOT ACCESSIBLE FOR EVALUATION AT THIS TIME. THERE IS NO CONFIRMATION OF ANY OF THE FIVE PATIENTS CONTRACTING CJD, OR OF THE PRESENCE OF CJD ON THE QUARANTINED INSTRUMENT SET. REMEDIAL ACTION NOTIFICATION: MEDTRONIC NAVIGATION INVESTIGATION IDENTIFIED FIVE SUBSEQUENT PROCEDURES ON FIVE SEPARATE PATIENTS, WHERE THE FEE-PER-USE (FPU) CRANIAL PASSIVE INSTRUMENT SET WAS USED: INITIAL EVENT) (B)(6) 2013 - CRANIAL; (B)(6) 2013 - LEFT PARIETAL BIOPSY; (B)(6) 2013 - CERVICAL FUSION; (B)(6) 2013 - TUMOR RESECTION; (B)(6) 2013 - CERVICAL FUSION; (B)(6) 2013 - CERVICAL FUSION. THIS INFORMATION HAS BEEN REPORTED TO THE AFFECTED STATE HEALTH AGENCIES AND HOSPITALS, WHERE THE CRANIAL PASSIVE INSTRUMENT SET WAS SUBSEQUENTLY USED: (B)(6). THIS REMEDIAL ACTION NOTIFICATION BEGAN ON (B)(4) 2013. THE CRANIAL PASSIVE INSTRUMENT SET HAS BEEN REMOVED FROM SERVICE, AND AT THE HOSPITAL REQUEST IS CURRENTLY IN QUARANTINE AT MEDTRONIC NAVIGATION, INC. MEDTRONIC NAVIGATION, INC. CONTINUES TO INVESTIGATE THE MATTER AND COMMUNICATE WITH THE THREE STATE HEALTH AGENCIES AND HOSPITALS. SUPPLEMENTAL MDRS WILL BE FILED AS REQUIRED, WHILE THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    ON (B)(4) 2013, A MEDTRONIC REPRESENTATIVE RECEIVED A REPORT THAT A FEE-PER-USE (FPU) CRANIAL PASSIVE INSTRUMENT SET (¿INSTRUMENT SET¿) HAD BEEN USED ON A PATIENT WHO WAS SUBSEQUENTLY DIAGNOSED WITH CREUTZFELDT-JAKOB DISEASE (CJD). THE INSTRUMENT SET WAS INITIALLY UTILIZED ON THAT PATIENT IN A CRANIOTOMY TO REMOVE AN ARACHNOID CYST ON (B)(6) 2013 AT A HOSPITAL IN (B)(6). AT TIME OF THIS PROCEDURE, IT WAS REPORTED THAT THE PROCEDURE WENT WELL AND THERE WERE NO ISSUES. FOLLOWING THE INITIAL PROCEDURE, THE PATIENT CONTINUED TO DETERIORATE, EVENTUALLY EXPIRING ON, OR ABOUT, (B)(6) 2013. AN AUTOPSY WAS PERFORMED ON THE DECEDENT, AND AN INITIAL CEREBROSPINAL FLUID (CSF) TEST INDICATED THE PRESENCE OF CJD PRIONS. THIS INITIAL TEST WILL BE FOLLOWED UP WITH A FINAL PATHOLOGY CONFIRMATION TEST, WHICH WILL TAKE SEVERAL WEEKS. MEDTRONIC NAVIGATION, INC. WILL FILE SUPPLEMENTAL MDRS TO REPORT ANY NEW INFORMATION. ON (B)(6) 2013, THE HOSPITAL NOTIFIED MEDTRONIC NAVIGATION, INC. AND THE (B)(6) STATE HEALTH DEPARTMENT OF THE INITIAL PATIENT DIAGNOSIS; WHO, IN TURN, NOTIFIED (B)(6) STATE HEALTH DEPARTMENTS OF WHERE THE CRANIAL PASSIVE INSTRUMENT SET HAD BEEN USED IN PROCEDURES SUBSEQUENT TO THE INITIAL REPORTED EVENT OF (B)(6) 2013. THE INSTRUMENT SET HAS BEEN REMOVED FROM SERVICE AND IS IN QUARANTINE AT MEDTRONIC NAVIGATION, INC. MEDTRONIC NAVIGATION, INC. IS FILING THIS MDR TO ENSURE VISIBILITY TO A PATIENT DEATH FROM CJD, AND USAGE OF THE INSTRUMENT SET IN FIVE SUBSEQUENT PROCEDURES INVOLVING FIVE PATIENTS IN (B)(6). THERE IS NO ALLEGATION THAT MEDTRONIC NAVIGATION'S INSTRUMENT SET CAUSED, OR CONTRIBUTED, TO THE REPORTED EVENT. THERE IS NO CONFIRMATION OF ANY OF THE FIVE PATIENTS CONTRACTING CJD, OR OF THE PRESENCE OF CJD ON THE QUARANTINED INSTRUMENT SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438474 CRANIAL PASSIVE INSTRUMENT SET NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death| O