STEALTHSTATION¿ S8 SYSTEM
Report
- Report Number
- 1723170-2023-01145
- Event Type
- Death
- Date Received
- July 7, 2023
- Date of Event
- June 14, 2023
- Report Date
- March 8, 2024
- Manufacturer
- MEDTRONIC NAVIGATION, INC
- Product Code
- HAW
- PMA / PMN Number
- K162309
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
H3, H6: ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE SITE VISIT FOR SERVICING. IT WAS CONFIRMED THAT NO HARDWARE PARTS WERE REPLACED. NO FAULT WAS FOUND. THE SYSTEM PASSED SYSTEM CHECKOUT AND WAS FUNCTIONING AS EXPECTED. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
H3,H6) NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. A1-5: SELECT PATIENT INFORMATION CANNOT BE PROVIDED DUE TO REGIONAL PRIVACY REGULATIONS. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
H3/H6: THE SOFTWARE ANALYSIS WAS COMPLETED. ANALYSIS DETERMINED THAT THERE WAS INSUFFICIENT INFORMATION TO DETERMINE THE CAUSE OF THE ISSUE BECAUSE LOGS COULD NOT BE OBTAINED FROM THE FACILITY. CODES B17, C19, AND D15 APPLY. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
H3, H6: ADDITIONAL INFORMATION WAS RECEIVED. REGARDING SERVICING. IT WAS FOUND THAT THERE WAS POOR ACCURACY SUSPECTED, HOWEVER, THERE WERE NO PROBLEMS IDENTIFIED WITH THE SYSTEM. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
D10: SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: SOFTWARE 9735740, VERSION: 2.1.0. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.
H3. THE SYSTEM WAS SERVICED IN THE FIELD, AND THE INFORMATION PROVIDED WAS UNCLEAR IF HARDWARE PARTS WERE REPLACED. ADDITIONAL FOLLOW-UP IS BEING PERFORMED. G3. AWARE/NOTIFY DATE HAS BEEN UPDATED TO 2023-06-20. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THERE WAS AN INACCURACY. CT SPINE ON A PATIENT ALREADY INSERTED A CAGE AT L2-L5. SEVERE HALATION AND REGISTRATION DIFFICULTIES WERE ANTICIPATED ON THE PREOPERATIVE CT. THE SCREW WAS INSERTED VISUALLY IN TH10-L1 AND IN L2-L5, THE SCREW WAS INSERTED USING A NAVIGATION SYSTEM. THE ACCURACY WAS NOT OBTAINED FROM S1, EVEN THOUGH IT WAS REGISTERED AGAIN, THE POINTS DID NOT MATCH, SO THE NAVIGATION USAGE WAS DISCONTINUED AND THE SCREW WAS INSERTED UNDER FLUOROSCOPY. DUE TO THIS, THE EXTENSION TIME IS ABOUT 15 MINUTES. AFTER THAT, THE PROCEDURE WAS COMPLETED AND THE SURGERY WAS OVER. THE FOLLOWING DAY, THE PATIENT DIED OF HEART DISEASE. IT IS UNKNOWN WHETHER THE DEATH WAS CAUSED BY THE FACT THAT THE NAVIGATION COULD NOT BE USED AND THE FACT THAT THE TIME WAS EXTENDED.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT A NAVIGATION SYSTEM USED IN A POSTERIOR CORRECTION AND FIXATION SURGERY FOR ASD (ADULT SPINAL DEFORMITY). IT WAS REPORTED THAT THE PATIENT DIED OF CARDIAC DEATH THE DAY AFTER SURGERY. ON THE DAY OF THE SURGERY, THE POSTERIOR FIXATION T10-SAI SCREW FIXATION AND THE L5/S PLIF (POSTERIOR LUMBAR INTERBODY FUSION) WERE PERFORMED. XLIF (EXTREME LATERAL INTERBODY FUSION) (ANOTHER COMPANY) PERFORMED AT L2-L5 THE WEEK BEFORE. A SCREW WAS INSERTED FROM THE CRANIAL; FOR T10-L1, THE SCREW INSERTION WAS PERFORMED BY INSPECTING VISUALLY, AND THE NAVIGATION SYSTEM CT SPINE WAS USED FROM THE L2 TO THE CAUDAL SIDE. THE SCREW INSERTION WAS COMPLETED WITHOUT ANY DOUBT OF ACCURACY UNTIL L5. IT WAS DETERMINED THAT THERE WAS AN ERROR IN ACCURACY IN S1, SO THE NAVI REGISTRATION POINT WAS RE-ESTABLISHED, BUT ACCURACY COULD NOT BE OBTAINED, AND S1/SAI WAS INSERTED UNDER THE IMAGE. (TIME LO SS OF ABOUT 15 MINUTES) FOR SAI, S5RMAS WAS USED RATHER THAN BALLAST. AFTERWARD, A GRADE 1 INTERVERTEBRAL JOINT OSTEOTOMY WAS PERFORMED, AND PLIF WAS PERFORMED AT L5/S. ROD PLACEMENT WAS PERFORMED WHILE RECTIFYING THE CANTILEVER USING ARI. AFTER COMPLETION, THE TAB WAS BENT, AND WHEN THE DOCTOR CHECKED THE MEP, THE POWER WAS OFF AND THE ROD WAS REMOVED. IT DID NOT RECOVER, SO IT WAS DETERMINED THAT THE NERVE HAD BECOME NARROWED DUE TO LORDOSIS IN THE LUMBAR VERTEBRA REGION DURING CORRECTION FROM THE TIME OF KYPHOSIS PRIOR TO THE PROCEDURE, AND L3-L5 WAS USED TO ADD AN ABRUPT LAMINECTOMY. THE RESPONSE TO THE MEP WAS RESTORED, SO THE ROD WAS PLACED AGAIN. THE TAB OF THE RMAS WAS BENT, AND THE ARI DID NOT REACH WHETHER THERE WAS A BURR IN ALMOST ALL SCREWS ON THE SCREW HEADS. AN ATTEMPT WAS MADE TO USE A CANTILEVER OR TRANSLATION USING THE NESPRON CABLE, BUT AFTER THE CABLE WAS PASSED THROUGH, THE USAGE METHOD OF THE TYING GUN WAS NOT KNOWN, AND THE NESPRON WAS RESECTIONED AND REMOVED. THE TWO-ROD REDUCERS WERE USED FREELY FOR THE ROD PLACEMENT. THE POST-OPERATIVE RECTIFICATION WAS NICELY PERFORMED. THE POINT WAS THAT THE NAVI POINT DID NOT WORK, SAI COULD NOT BE INSERTE D UNDER NAVI, AND THERE WAS SOME RECONSIDERATION ON THE DIFFICULTIES WITH ROD PLACEMENT BECAUSE THE MEP WAS CHECKED AFTER THE RMAS TAB WAS BENT, BUT THE RECTIFICATION WENT WELL AND PROPERLY. THERE WAS NO DISCUSSION ABOUT HEMORRHAGE AT THIS POINT. AFTERWARD, IT WAS INQUIRED ABOUT THE PATIENT'S DEATH; IT WAS TOLD THAT THE PATIENT ORIGINALLY HAD A HEART CONDITION AND THAT THE AMOUNT OF BLOOD LOSS THAT DAY MAY HAVE RESULTED IN THE PATIENT'S DEATH. HOWEVER, THE DOCTOR OF (B)(6) WAS ALSO IN OPERATION THAT DAY, AND WHEN THE DOCTOR WAS ALSO ASKED FOR THEIR OPINION, THE DOCTOR RESPONDED THAT THEY COULD NOT DETERMINE THAT THE CAUSE WAS THE AMOUNT OF HEMORRHAGING. THE PROCEDURE WOULD HAVE BEEN COMPLETED IN LESS TIME THAN THE ACTUAL TIME TAKEN, AND THE BLEEDING MIGHT HAVE BEEN LESS, FOR INSTANCE, GIVEN THE TIME ELAPSED USING NAVI, THE FACT THAT DECOMPRESSION WAS ADDED, AND THE DIFFICULTY WITH THE ROD PLACEMENT. ON THE OTHER HAND, WHEN A FOLLOW-UP WAS MADE WITH THE DOCTOR OF (B)(6), IT WAS STATED THAT THE HEMOSTATIC AGENT COULD NOT BE REMOVED DURING THE SURGERY (ONLY ONE OF THE SURGIFLO COULD BE USED) AND THE PATIENT WAS NOT IN THE ICU AFTER THE SURGERY. ADDITIONAL INFORMATION RECEIVED FROM MANUFACTURER REPRESENTATIVE THAT THE PHYSICIAN HAD COMMENTED THAT THE MEDTRONIC PRODUCT WAS NOT A DIRECT CAUSE OF DEATH. ON THE OTHER HAND, THE SURGICAL TIME WAS EXTENDED BECAUSE THE NAVI REGISTRATION COULD NOT BE ACHIEVED WITH MEDTRONIC PRODUCT AND THE S1 AND SAI SCREWS WERE INSERTED UNDER FLUOROSCOPY; AFTER THE MARS TAB WAS FOLDED, THE ROD WAS REMOVED AND THE ARI COULD NOT BE APPLIED AT ALL DURING RE-ANCHORING. THIS MIGHT BE A DISTANT CAUSE. THE SURGICAL TIME WAS APPROXIMATELY 1 HOUR FROM ENTERING THE PATIENT TO THE START OF THE SURGERY, AND APPROXIMATELY 7 HOURS FROM THE START OF THE SURGERY TO INCISION CLOSURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 640039 | STEALTHSTATION¿ S8 SYSTEM | NEUROLOGICAL STEREOTAXIC INSTRUMENT | HAW | MEDTRONIC NAVIGATION, INC | 9735665 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male | Death | SEE H10. |