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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY UNKNOWN CATHETER SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

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MEDTRONIC NEUROSURGERY UNKNOWN CATHETER SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number UNKNOWN-C
Device Problems Disconnection (1171); Malposition of Device (2616); Device Dislodged or Dislocated (2923); Positioning Problem (3009)
Patient Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930); No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Event Date 09/22/2017
Event Type  Injury  
Manufacturer Narrative
Age/date of birth. Please note that this age is the average age of the patients reported in the article, as the actual age of patients involved was not provided. Sex. Please note that this is the gender of the majority of patients reported in the article as the actual genders of patients involved was not provided. Date of event. Please note that this date is based off the date of publication of the article as the actual event date was not provided. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Patrick schuss, christian wispel, valeri borger, ági güresir, hartmut vatter, erdem güresir. Accuracy and safety of ventriculostomy using two different procedures of external ventricular drainage: a single-center series. Journal of neurological surgery 79 (2018). Doi: 10. 1055/s-0037-1606544. Abstract: background and study aims patients with acute hydrocephalus are treated by either insertion of a conventional external ventricular drain (evd) or percutaneous needle trephination (pnt) at our institution, depending on the acuteness of intervention and the severity of illness. We compared both procedures regarding accuracy and safety necessitating surgical revision of evd or pnt. Methods between january 2012 and january 2014, 451 ventriculostomies were performed in 301 patients at our institution. All patients underwent routine computed tomography after insertion of the ventricular drain during the treatment course. Patient characteristics, underlying pathology, ventriculostomy modality, radiologic features, catheter tip location, and treatment-related complications were analyzed. Results a total of 307 of 451 ventriculostomy procedures (68%) were performed as conventional evd, and 144 (32%) were performed as pnt. Overall, 11% of patients with conventional evd underwent surgical revision due to lacking accuracy, infection, or hemorrhage; 7% of patients with pnt underwent surgical revision (p ¼ 0. 2). However, multivariate analysis revealed that only ¿hospital stay > 21 days¿ as an independent variable was significantly associated with surgical revision after ventriculostomy. Conclusion the present data indicate that pnt has a similar safety profile in emergency situations in critically ill patients who need immediate treatment for acute hydrocephalus when compared with the conventional evd procedure. Reported events. A total of 5 conventional evd patients underwent surgical revision due to catheter tip misplacement. A total of 16 conventional evd patients underwent surgical revision due to catheter dislocation during their treatment course.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand NameUNKNOWN CATHETER
Type of DeviceSHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
Manufacturer (Section D)
MEDTRONIC NEUROSURGERY
125 cremona drive
goleta CA 93117
Manufacturer (Section G)
MEDTRONIC NEUROSURGERY
125 cremona drive
goleta CA 93117
Manufacturer Contact
stacy ruemping
7000 central avenue ne rcw215
minneapolis, MN 55432
7635260594
MDR Report Key7732393
MDR Text Key115468007
Report Number2021898-2018-00378
Device Sequence Number0
Product Code JXG
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/30/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN-C
Device Catalogue NumberUNKNOWN-C
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 Received08/08/2018
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

Patient Treatment Data
Date Received: 07/30/2018 Patient Sequence Number: 1
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