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

Model Number S7

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

Patient Problems Muscle Weakness (1967); Myocardial Infarction (1969); Spinal Column Injury (2081); Urinary Retention (2119); Discomfort (2330); Iatrogenic Source (2498)

Event Date 04/22/2016

Event Type  Injury  

Manufacturer Narrative

Table 1 details the patient demographic and procedural data.A total of 31 consecutive patients underwent the procedure.The mean age was 63.9 years (range 24¿79 years).Ten patients were male and 21 patients were female.The average body mass index was 31.0 kg/m2 (range 24.2¿47.1 kg/m2).Reported complications are known inherent risks to this type of procedure.And related to the surgical approach per article.No allegation of malfunction.No requests for service were received regarding these events.

Event Description

Per attached journal article, use of 3d ct-based navigation in minimally invasive lateral lumbar interbody fusion by joseph et al, a total of 31 consecutive patients underwent the procedure.The mean age was 63.9 years (range 24¿79 years).Ten patients were male and 21 patients were female.The average body mass index was 31.0 kg/m2 (range 24.2¿47.1 kg/m2).A total of 66 levels were fused (mean 2.1 levels fused per patient; range 1¿4 levels fused per patient).Thirteen patients underwent single-level fusions, while 18 had multilevel fusions (fig.5).Preoperative diagnoses included degenerative kyphoscoliosis, idiopathic scoliosis, adjacent segment disease, and pseudoarthrosis.Twenty-six procedures were performed using a left-sided approach, and 5 procedures were performed via a right-sided approach.A single icbct image was acquired for each patient, and no reregistration was required.Nine patients had approach related complications; 8 of these complications consisted of transient, mild paresthesias or hip flexion weakness.One patient developed a psoas muscle abscess.There were no further surgical-site infections.Three patients had mild (grade 4+/5 on the medical research council criteria) residual hip flexion weakness at 1-month follow-up.Four patients had medical complications, including 2 patients with myocardial infarction, 1 of which was a non¿st-segment elevation associated with atrial fibrillation and rapid ventricular response.Both of these patients had a second-stage posterior procedure.The other 2 medical complications consisted of 1 patient who developed the miller-fisher variant of acute, intermittent demyelinating polyneuropathy, and another patient who developed urinary retention.All of these patients made a complete recovery with no residual effects.There was 1 patient in whom the attempted cage placement was aborted due to an end plate fracture that occurred during disc preparation.The igns (image guidance navigation system) was used for each level fused.There were no instances of inaccuracy at any level in either the single level or multilevel procedures.Postoperative imaging confirmed the expected placement of the cages based on the igns plan.Twenty-eight cages (42.4%) were placed that spanned quarters 1 to 2, 36 cages (54.5%) spanned quarters 2 to 3, and 2 cages (3.0%) spanned quarters 3 to 4.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.There is no allegation to suggest that medtronic navigation's device caused or contributed to the reported event.

• Brand Name: STEALTHSTATION S7 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 ; 826 coal creek circle; louisville, CO 80027 ; 7208902092
• MDR Report Key: 6304037
• MDR Text Key: 66597975
• Report Number: 1723170-2017-00369
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994450944
• UDI-Public: 00613994450944
• 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
• Report Date: 02/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: S7
• Device Catalogue Number: 9733856
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2013
• 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; Disability
• Patient Age: 64 YR