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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY UKNOWN SEPS KIT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

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MEDTRONIC NEUROSURGERY UKNOWN SEPS KIT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number 11-0401-CAL
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Insufficient Information (4580)
Event Date 04/24/2021
Event Type  Death  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Austin carpenter, mitchell rock, ehsan dowlati, charles miller, jeffrey c. Mai, ai-hsi liu, rocco a. Armonda, daniel r. Felbaum. Middle meningeal artery embolization with subdural evacuating port system for primary management of chronic subdural hematomas. Neurosurgical review (2021). Doi: 10. 1007/s10143-021-01553-x abstract optimal treatment for chronic subdural hematomas remains controversial and perioperative risks and comorbidities may affect management strategies. Minimally invasive procedures are emerging as alternatives to the standard operative treatments. We evaluate our experience with middle meningeal artery (mma) embolization combined with subdural evacuating port system (seps) placement as a first-line treatment for patients with csdh. A single institution retrospective review was performed of all patients undergoing intervention. Patients were stratified by treatment with mma embolization and seps placement, mma embolization and surgery, seps placement only, and surgery only for csdh from 2017 to 2020, and cohorts were compared against each other. Patients treated with mma/seps were more likely to be older, be on anticoagulation, have significant comorbidities, have shorter length of stay, and less likely to have symptomatic recurrence compared to seps only cohort. Thus, mma/seps appears to be a safe and equally effective minimally invasive treatment for csdh patients with significant comorbidities who are poor surgical candidates. Reported events. - 30-day mortality for the mma embolization + seps included 1 patient. - 30-day mortality for seps only included 2 patients.
 
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Brand NameUKNOWN SEPS KIT
Type of DeviceSHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
Manufacturer (Section D)
MEDTRONIC NEUROSURGERY
5290 california ave
irvine CA 92617
Manufacturer (Section G)
MEDTRONIC NEUROSURGERY
5290 california ave
irvine CA 92617
Manufacturer Contact
david gustafson
9775 toledo way
irvine, CA 92618
7635149628
MDR Report Key12558468
MDR Text Key274199568
Report Number2021898-2021-00172
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUS
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 09/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number11-0401-CAL
Device Catalogue Number11-0401-CAL
Device Lot NumberUNKNOWN
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 Received09/15/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/30/2021 Patient Sequence Number: 1
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