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

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.

• Brand Name: LANDMARX ELEMENT OR ENT
• 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
• MDR Report Key: 6966574
• MDR Text Key: 89918518
• Report Number: 1723170-2017-04244
• 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,health
• Reporter Occupation: Physician
• 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 Received: 10/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: ELEMENT OR ENT
• Device Catalogue Number: 9731439XOM
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2017
• 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 Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other; Required Intervention
• Patient Age: 51 YR