NEUROLOGICAL STEREOTAXIC INSTRUMENT

Report

Report Number: 1723170-2015-01222
Event Type: Injury
Date Received: October 26, 2015
Date of Event: September 14, 2015
Report Date: January 21, 2016
Manufacturer: MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
Product Code: HAW
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

THE SITE DECLINED TO PROVIDE PATIENT INFORMATION, GENDER AND WEIGHT PER (B)(6) PRIVACY LAWS. PROCODE IS HAW. DEVICE LOT NUMBER NOT AVAILABLE. 510(K) IS K050438. DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER, THEREFORE, UNAVAILABLE. ON 10/02/2015 A MEDTRONIC REPRESENTATIVE PERFORMED A NAVIGATION SYSTEM CHECK-OUT, ALL AREAS PASSED. SYSTEM PERFORMED AS INTENDED. CHECKED-OUT THE INSTRUMENTS AND THE PASSIVE PLANAR DID NOT HAVE AN ISSUE. THE PEDICLE PROBE WAS CLEARLY INACCURATE. NO PARTS HAVE BEEN RECEIVED BY MANUFACTURER FOR ANALYSIS.

Additional Manufacturer Narrative · 1

DEVICE LOT# AND MFG DATE NOW PROVIDED.

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION: A MEDTRONIC REPRESENTATIVE REPORTED THAT ACCORDING TO THE REP, THE HOSPITAL AND THE REP DID NOT CONFIRM THE EXACT AMOUNT OF INACCURACY DURING THE SURGERY. THERE HAVE BEEN NO FURTHER DETAILS REPORTED FROM THE SITE REGARDING THE PATIENT'S CURRENT STATUS. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE A SECOND TIME TO TEST THE EQUIPMENT. THE HARDWARE, SOFTWARE, AND INSTRUMENTS PASSED THE SYSTEM CHECKOUT. THE SYSTEM WAS FOUND TO BE FULLY FUNCTIONAL. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE RETURNED PROBE WAS FOUND TO BE IN GOOD CONDITION WITH NO APPARENT PHYSICAL DAMAGE. WITH MARKERS ATTACHED AND FULLY SEATED, THE PROBE RETURNED GOOD GEOMETRY AND DIVOT ERROR READINGS. THE DEVICE WAS FOUND TO BE FULLY FUNCTIONAL WITH NO PROBLEM FOUND. THE REPORTED EVENT COULD NOT BE DUPLICATED BY MEDTRONIC PERSONNEL.

Additional Manufacturer Narrative · 1

SUSPECT DEVICE WAS EVALUATED BY A CROSS-FUNCTIONAL ENGINEERING TEAM. ENGINEERING EVALUATION VERIFIED NO PHYSICAL OR HANDLING DAMAGE WHICH WOULD ADVERSELY AFFECT NAVIGATION. THE RETURNED PROBE WAS TESTED WITH A CERVICAL SPINE DEMO USING SPINAL SW TO VERIFY THE ACCURACY OF THE INSTRUMENT. THE PROBE WAS REGISTERED AND SUCCESSFULLY NAVIGATED USING SPINAL SW WITHOUT INCIDENT. THE RETURNED PROBE IS NOT THE CAUSE OF THE REPORTED CONDITION. NO PROBLEM FOUND. NO FURTHER INVESTIGATION INFORMATION HAS BEEN PROVIDED TO INDICATE THE CAUSE OF THE INACCURACY. NO FURTHER RELEVANT ISSUES REPORTED.

Description of Event or Problem · 1

A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A POSTERIOR CERVICAL SPINE PROCEDURE, NAVIGATION WAS USED FOR C2 AND C4, WITH A LAMINA SCREW IMPLANTED IN C2 AND A PEDICLE SCREW IN C4. WHEN THE PLACEMENT WAS CHECKED USING THE C-ARM THE POINT OF NAVIGATION WAS FOUND DISPLACED. NAVIGATION WAS NOT USED FOR C5, ALTHOUGH IT WAS PLANNED INITIALLY, AND THE SCREW WAS IMPLANTED IN C5 USING THE C-ARM ONLY. AS A RESULT, THE SCREW WAS PROPERLY PLACED ONLY IN C5, WHEREAS CONSIDERABLE DISPLACEMENT WAS OBSERVED IN C2 AND C4. IN C4, THE SCREW PERFORATED THROUGH THE TRANSVERSE FORAMEN. THE PATIENT WAS CONFIRMED TO HAVE NERVE PARALYSIS (IT IS RATHER HARD FOR THE PATIENT TO RAISE THE RIGHT ARM). THE DOCTOR SAID RE-POSITIONING OF THE SCREWS WAS IMPOSSIBLE AT THIS MOMENT CONSIDERING THE CURRENT SITUATION BECAUSE REMOVING THE SCREWS COULD CAUSE OTHER ADVERSE EVENTS SUCH AS DAMAGE ON THE BLOOD VESSELS OR CEREBRAL INFARCTION DUE TO THROMBUS. THERE WAS NO DELAY OF THERAPY REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
707906		NEUROLOGICAL STEREOTAXIC INSTRUMENT	HAW	MEDTRONIC NAVIGATION, INC. (LOUISVILLE)		080408

Patients

Seq	Age	Sex	Outcome	Treatment
1	75 YR		Required Intervention\| S