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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC MEDTRONIC NAVIGATION INSTRUMENT, STEREOTAXIC

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MEDTRONIC NAVIGATION, INC MEDTRONIC NAVIGATION INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number UNK_NAV_SYS
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Headache (1880); Muscle Weakness (1967); Unspecified Tissue Injury (4559)
Event Date 06/09/2019
Event Type  Injury  
Manufacturer Narrative
Patient age is the mean value of the patients who experienced adverse events in the study. Patient gender was the majority value of patients in the study who experienced adverse events in the study. Patient weight not available from the site. Event date is the accepted date of the publication. Device lot number, or serial number, unavailable. No parts have been received by the manufacturer for evaluation. Device manufacturing date is dependent on lot number/serial number, therefore, unavailable. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Citation: jonathan parish, matthew mcpheeters, scott d. Wait. Endoscopic management of benign cystic lesions of the thalamus with fenestrated stent placement. Journal of clinical neuroscience 67 (2019) 226-230. Https://doi. Org/10. 1016/j. Jocn. 2019. 06. 028 abstract: benign intracranial cystic lesions of the thalamus are an uncommon clinical entity rarely requiring operative decompression. In combination with cyst fenestration, cerebrospinal fluid (csf) flow diversion or fenestrated stent placement may be performed at the time of surgery. We describe a method of treatment of these cysts using endoscopic cyst fenestration with fenestrated transventricular stent placement. Three patients with benign cystic lesions were treated with stereotactic-guided, endoscopic fenestration and fenestrated stent placement. All 3 had radiographic and clinical improvement. There were no complications. Endoscopic fenestration and transventricular fenestrated stent placement is a minimally invasive, effective, and safe method to decompress benign, symptomatic cystic lesions of the thalamus. Reported events: (b)(6) male experienced a mild headache and progressive left sided weaknessat four months post-operative. The patient subsequently underwent an additional fenestration and fenestrated stent placement which resolved the symptoms. (b)(6) male experienced displacement of their stent. The patient underwent a redo cyst fenestration and third ventriculostomy.
 
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Brand NameMEDTRONIC NAVIGATION
Type of DeviceINSTRUMENT, STEREOTAXIC
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer (Section G)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer Contact
tricha miles
7000 central avenue ne rcw215
minneapolis, MN 55432
7635140379
MDR Report Key11047854
MDR Text Key226797202
Report Number1723170-2020-03359
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 health professional,literatur
Reporter Occupation
Type of Report Initial
Report Date 12/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNK_NAV_SYS
Device Catalogue NumberUNK_NAV_SYS
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/08/2020
Was Device Evaluated by Manufacturer? No
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: 12/21/2020 Patient Sequence Number: 1
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