BEUDAMED
    FDA Adverse Event Death Summary report: N

    STEALTH INAV PORTABLE SYSTEM

    MDR report key: 3026012 · Received March 28, 2013

    Report

    Report Number
    1723170-2013-00228
    Event Type
    Death
    Date Received
    March 28, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 28, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WEIGHT IS UNKNOWN. NO PARTS OR FILES HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION AS NO MALFUNCTION WAS ALLEGED.

    Additional Manufacturer Narrative · 1

    CORRECTION: IT WAS DISCOVERED ON 01/27/2014 THAT THE STATEMENT REPORTED ON 1723170-2013-00228 FOLLOW UP #1 REFERENCE THE INCORRECT SYSTEM TYPE. PLEASE SEE BELOW FOR CORRECTED STATEMENT:"WHILE THE PROCEDURE ON THE PATIENT UTILIZED MEDTRONIC NAVIGATION'S STEALTH INAV PORTABLE SYSTEM, THERE WAS NO ALLEGATION TO SUGGEST THAT MEDTRONIC NAVIGATION'S SYSTEM CAUSED OR CONTRIBUTED TO THE REPORTED EVENT."TO FURTHER CLARIFY THE SYSTEM INVOLVED IN THE REPORTED EVENT WAS A STEALTH INAV PORTABLE SYSTEM, NOT STEALTHSTATION S7 SYSTEM.

    Additional Manufacturer Narrative · 1

    TYPE OF REPORTABLE EVENT FIELD SHOULD HAVE INITIALLY BEEN FILED AS DEATH, NOT AS MALFUNCTION. THIS MDR WAS FILED DUE TO REPORT OF PATIENT DEATH. WHILE THE PROCEDURE ON THE PATIENT UTILIZED MEDTRONIC NAVIGATION'S STEALTHSTATION S7 SYSTEM, THERE WAS NO ALLEGATION TO SUGGEST THAT MEDTRONIC NAVIGATION'S SYSTEM CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED LEGAL DOCUMENTS RELATED TO A CASE AT (B)(6) FROM (B)(6) 2011 THAT REFERENCE MEDTRONIC NAVIGATION AS BEING USED IN THE SURGERY. NO INFORMATION CONTAINED IN THE LEGAL DOCUMENTS PROVIDED INDICATE ANY ALLEGED MALFUNCTION OF A MEDTRONIC NAVIGATION DEVICE. NEUROSURGEON OPERATIVE REPORT STATES "THE STEREOTACTIC NEURONAVIGATION WAS UTILIZED TO VERIFY THE LOCATION OF THE SPHENOID SINUS AND SELLA AND THE MASS DURING THE PROCEDURE BY BOTH MYSELF AND [ENT SURGEON]." THERE WERE NO COMPLICATIONS. ENT SURGEON OPERATIVE REPORT DOES NOT DESCRIBE UNEXPECTED FINDINGS DURING HIS PORTION OF SURGERY, AND CONTINUES "THE PATIENT DID WELL, WOKE UP IN A STABLE CONDITION. THE PATIENT LATER ON THAT DAY UNFORTUNATELY WAS RESPONDING TO PAIN, BUT ACCORDING TO THE SURGICAL NOTE, THERE WAS CONCERN THAT SHE WAS NOT VERY ALERT. SHE UNDERWENT A HEAD CT AND THE HEAD CT SHOWED THAT SHE HAD SOME BLEEDING INTRACRANIALLY. SO THE PATIENT UNDERWENT THE PLACEMENT OF A RIGHT VENTRICULAR CATHETER." LEGAL DOCUMENT STATES THAT DURING THE PLACEMENT OF THE CATHETER " DR PLACED THE VENTRICULOSTOMY TUBE INCORRECTLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127878 STEALTH INAV PORTABLE SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. INAV PORTABLE

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death