MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 PLANNING STATION; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number S7 PLANNING STATION

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

Patient Problems Neurological Deficit/Dysfunction (1982); Therapeutic Response, Decreased (2271); Depression (2361); Iatrogenic Source (2498)

Event Date 01/20/2016

Event Type  Injury  

Manufacturer Narrative

No patient ids or weights were provided by the authors.Saleh s, swansen kl, lake wb, et al.Awake neurophysiologically guided versus asleep mri-guided stn dbs for parkinson disease: a comparison of outcomes using levodopa equivalents.Stereotact funct neurosurg (2015);93:419¿426 doi: 10.1159/000442425.The exact system information could not be determined as it was not provided.However, the system listed on this form was at the address listed in the article during the time the surgeries were completed.No requests for system service have been received regarding the reported events.The article does not allege that the medtronic system caused the reported events.Reported events are known inherent risks to this procedure type.The article concludes that overall, use of the navigation system reduces complications.

Event Description

The attached journal article, awake neurophysiologically guided versus asleep mri-guided stn dbs for parkinson disease: a comparison of outcomes using levodopa equivalents by saleh, swansen, lake et all, was reviewed and it was found that adverse events were reported.Medtronic framelink software was used to plan lead placement in the awake group.Please see article excerpts below for further details: one patient from the awake group required the repositioning of both leads (the first 3 days after implantation and the second 1.5 years later).It was also reported that a patient from the awake group had a thalamic stroke.Furthermore, 3 patient experienced postoperative depression, 7 patients experienced dysarthria, 5 dysphagia, 7 gait difficulty and 2 fatigue.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 s7 navigation system.There is no allegation to suggest that medtronic navigation's device caused or contributed to the reported event.

Manufacturer Narrative

Additional investigation and journal article review was conducted.It was confirmed there is no allegation to suggest that medtronic navigation's device caused or contributed to the reported event.Several system checkout have been completed on this suspected system since the event date per system history and confirmed the system performed as intended.Additional information: the journal article also reported: "brain shift and "other factors" to have caused the suboptimal lead placement.

Manufacturer Narrative

Correction: device manufacturing date now provided.

• Brand Name: STEALTHSTATION S7 PLANNING STATION
• 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: oksana ditolla ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902092
• MDR Report Key: 6606958
• MDR Text Key: 76479250
• Report Number: 1723170-2017-02304
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994532398
• UDI-Public: 00613994532398
• 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,health
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 08/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: S7 PLANNING STATION
• Device Catalogue Number: 9734048
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2011
• 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: 61 YR