MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number I7

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Muscle Weakness (1967); Seizures (2063); Iatrogenic Source (2498)

Event Date 03/01/2012

Event Type  Injury  

Manufacturer Narrative

Patient ids and weights were not provided by the authors.Reported complications are known inherent risks of this type of procedure.There is no allegation of malfunction and there have been no requests for service from this user.Therefore, no system evaluation required.

Event Description

(b)(4).Medtronic representative summarized the relevant information below.Authors yao c, wu j, zhuang d, guo j, jiang l, qiu t, mao y, zhou l.Title: preliminary application of intraoperative mri multimodal image navigation in puncture biopsy of intracranial disease journal chin j nerv ment dis year/volume/pages 2012 vol 38(3) pgs 182-185.Article number doi:10.3969 / j.Issn.1002-0152.2012.03.010.(b)(6).Patients: 23 patients.Indication: puncture biopsy of intracranial tumors.Devices used: stealthstation i7 (verbatim: ¿tria i7¿); navigus system.Ae: one patient had hematoma at the puncture site > 30 ml, and craniotomy was required.The patient had muscle weakness on the corresponding side, which recovered as of follow-up at 2 months.One patient had epileptic seizure postoperatively.There was no stated root cause and no allegation the adverse events were caused by use of stealthstation or navigus systems.Patients: 12 males and 11 females.Patients (b)(6), mean (40.2 ± 15.8) years.Medtronic navigation is filing this mdr to ensure visibility to a patient event as a result of a procedure that utilized medtronic navigation's stealthstation i7.There is no allegation to suggest that medtronic navigation's device caused or contributed to the reported event.

Manufacturer Narrative

Specific patient ids and weights were provided by the author of the following article: "yao c, wu j, zhuang d, guo j, jiang l, qiu t, mao y, zhou l.Preliminary application of intraoperative mri multimodal image navigation in puncture biopsy of intracranial disease.Chin j nerv ment dis, 2012, 38(3): 182-185.(chinese)¿ on july 10, 2017.In the mentioned article, one patient had (b)(6) and weight is (b)(6) kg.Another patient had epileptic seizure postoperatively, whose id is (b)(6), and weight is (b)(6) kg.

• Brand Name: STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: catherine eaton ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902092
• MDR Report Key: 6337126
• MDR Text Key: 67647480
• Report Number: 1723170-2017-00370
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 07/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: I7
• Device Catalogue Number: 9734061
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR