• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSTEALTHSTATION S7 SYSTEM
Type of DeviceNEUROLOGICAL 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 Key6304037
MDR Text Key66597975
Report Number1723170-2017-00369
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K050438
Number of Events Reported1
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 Received02/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberS7
Device Catalogue Number9733856
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/10/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/04/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 02/06/2017 Patient Sequence Number: 1
-
-