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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY VENTRICLEAR II VENTRICULAR DRAINAGE CATHETER SET CATHETER, VENTRICULAR (CONTAINING ANTIBIOTIC OR ANTIMICROBIAL AGENTS)

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MEDTRONIC NEUROSURGERY VENTRICLEAR II VENTRICULAR DRAINAGE CATHETER SET CATHETER, VENTRICULAR (CONTAINING ANTIBIOTIC OR ANTIMICROBIAL AGENTS) Back to Search Results
Model Number 50318
Device Problem Fluid Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/17/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the doctor felt that the product had changed in the last couple of months. There had been leaking of cerebrospinal fluid around the catheter where the stitches are placed. They also noted that it felt like a new softer material.
 
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Brand NameVENTRICLEAR II VENTRICULAR DRAINAGE CATHETER SET
Type of DeviceCATHETER, VENTRICULAR (CONTAINING ANTIBIOTIC OR ANTIMICROBIAL AGENTS)
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 Key10436810
MDR Text Key203893911
Report Number2021898-2020-00216
Device Sequence Number1
Product Code NHC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K071640
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/31/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/10/2022
Device Model Number50318
Device Catalogue Number50318
Device Lot NumberNS13037539
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 Received08/31/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/02/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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