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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY UNKNOWN STRATA VALVE/SHUNT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

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MEDTRONIC NEUROSURGERY UNKNOWN STRATA VALVE/SHUNT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number UNKNOWN-S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930)
Event Date 06/26/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Aijun peng , ming yang , hai zhao , yongkang wu , yi zhao & liangxue zhou. Compared with conventional procedures, an intraoperative navigation system for ventriculoperitoneal shunting via the occipital horn improves outcomes in patients with hydrocephalus. British journal of neurosurgery (2020). Doi: 10. 1080/02688697. 2020. 1789555 abstract background: ventriculoperitoneal shunting (vps) is a common neurosurgical procedure used to treat hydrocephalus. Although the use of a navigation system in vps achieves superior results compared with conventional surgery, the relationships among clinical symptoms, ventricular catheter placement, catheter obstruction, and the postoperative evans index have not been clearly reported. Methods: we performed a retrospective study of 40 patients with vps (the navigation surgery group) and 31 patients with vps (the conventional surgery group). Clinical data, follow-up times, catheterization accuracy, postoperative outcomes, cumulative survival times, and correlations between catheter placement and obstruction, symptom grade and the postoperative evans index were analyzed. Results: thirty-seven patients experienced optimal ventricular catheter placement (grade 1), three experienced suboptimal placements (grade 2), and none experienced poor ventricular catheter placement (grade 3) in the navigation surgery group. Greater improvement in postoperative symptoms (p<(><<)>0. 001), including less catheter readjustment (p<(><<)>0. 001), was observed in the navigation surgery group. A kaplanmeier analysis showed that the cumulative catheter obstruction-free survival time was longer in the navigation surgery group (p¿0. 016). Moreover, catheter placement was significantly correlated with catheter obstruction (p <0. 001). Additionally, catheter obstruction was significantly correlated with the symptom grade (p <0. 001) and postoperative evans index (p¿0. 002). Conclusion: vps for hydrocephalus via the occipital horn with a navigation system is superior to the conventional surgical procedure in terms of clinical outcomes, the precision of ventricular catheterization, and the occurrence of complications. Catheter obstruction-free survival times were longer in the navigation surgery group and catheter placement was significantly correlated with catheter obstruction. Reported events. - 1 patient in the conventional surgery group experienced a postoperative infection. - 1 patient in the conventional surgery group experienced bleeding.
 
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Brand NameUNKNOWN STRATA VALVE/SHUNT
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
tricha miles
9775 toledo way
irvine, CA 92618
7635140379
MDR Report Key11058314
MDR Text Key223617212
Report Number2021898-2020-00376
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNKNOWN-S
Device Catalogue NumberUNKNOWN-S
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 Received01/11/2021
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: 12/22/2020 Patient Sequence Number: 1
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