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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) LANDMARX ELEMENT OR ENT NEUROLOGICAL STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) LANDMARX ELEMENT OR ENT NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number ELEMENT OR ENT
Device Problem Imprecision (1307)
Patient Problems Intracranial Hemorrhage (1891); Unspecified Infection (1930); Brain Injury (2219); Iatrogenic Source (2498)
Event Date 11/12/2015
Event Type  Injury  
Manufacturer Narrative
Patient identifier and weight not made available by the journal article authors. Patient age and patient sex not made available by the authors. The article reports that the mean patient age was 51 years and the study cohort consisted of 35 male (51%) patients in the frameless group and therefore used. Event date is approximated. Date provided is when the journal article was accepted. 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 some of the surgeries were completed. Device udi not provided as this product is no longer manufactured. Citation: kennedy, bc, brown, lt, komotar, rj & mckhann 2nd, gm. Frameless stereotactic ommaya reservoir placement: efficacy and complication comparison with frame-based technique. Stereotact funct neurosurg 2015;93:415¿418. Doi: 10. 1159/000442423. Device manufacturing date is unavailable. Multiple attempts have been made to obtain additional information. No further information provided in the journal article or from the authors. The author could not provide any additional information or insight as he was not at the site when the surgeries were performed. No request for service have been received from the customer regarding these events. No parts have been replaced or returned to the manufacturer for evaluation. Per the journal article, both infections in the frameless group were delayed more than 30 days, consistent with the patients¿ immunocompromised state rather that the surgical procedure itself. All 3 symptomatic hemorrhages in the frameless group occurred in the context of thrombocytopenia or therapeutic anticoagulation in the perioperative period and are also unlikely to be attributable to the choice of stereotactic technique. There was 1 idiopathic malfunction and 1 malfunction due to delayed migration in this group. Which highlights the importance of securing the ommaya system well to extracranial tissue.
 
Event Description
The attached journal article was forwarded by a medtronic representative. Use of the navigation system was reported. This is medical device report (mdr) one of two. See 1723170-2017-04245 for second mdr. A total of 109 image-guided stereotactic ommaya reservoir placement procedures were performed at (b)(6) between 1998 and 2013 for leptomeningeal carcinomatosis. Forty-one (38%) surgeries were frame based, and 68 were frameless. The mean patient age was 51 years and the study cohort consisted of 35 male patients in the frameless group. For frameless stereotactic procedures, the scalp anatomy was coregistered to the volumetric imaging study using either surface registration with brain-lab z touch software or fiducial registration with the stealth system. The frame-based procedures only used brainlab. The primary outcome variable studied was rate of successful placement. Also studied were rates of revision, removal, procedure-related neurological morbidity, infection, intracranial hemorrhage, direct parenchymal toxicity and 30-day in-hospital mortality. For this patient population with diminished ventricular volume, use of stereotaxy for placement of these devices may improve accuracy, safety and ease. The study found that a minority of patients exhibited mild ventriculomegaly [14/41 (34%)], 2/68 (2. 9%) patients in the frameless group required 2 passes. There were no poor placements in the frameless group. Regarding accuracy, 100% of frameless patients evaluated with a postoperative scan demonstrated good placement. Complications in the study for frameless stereotaxy were reported as the following: two patients required catheter replacement surgery. Each group had two ommaya systems removed completely for infection. Two patients experienced asymptomatic blood noted on postoperative ct. Ten percent (7/68) of the patients in the frameless group experienced complications: 3 symptomatic hemorrhages, 2 delayed infections, 1 delayed migration with malfunction and 1 idiopathic malfunction. The author's reported that this study demonstrated excellent accuracy, a low complication rate and a low revision rate.
 
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Brand NameLANDMARX ELEMENT OR ENT
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
oksana ditolla
attn:product quality experienc
826 coal creek circle
louisville, CO 80027-9710
MDR Report Key6966574
MDR Text Key89918518
Report Number1723170-2017-04244
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
Type of Report Initial
Report Date 10/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberELEMENT OR ENT
Device Catalogue Number9731439XOM
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/26/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 10/20/2017 Patient Sequence Number: 1
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