• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC NEUROSURGERY UNKNOWN CATHETER SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Catalog Number UNKNOWN-C
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Hemorrhage, Subarachnoid (1893); Hemorrhage, Subdural (1894)
Event Date 01/10/2014
Event Type  Injury  
Manufacturer Narrative
These events were identified during review of scientific literature. The article contained only limited and non-specific device information. Contact with the corresponding author has been unsuccessful in yielding additional device information. The event reported in the source literature could not be matched to information previously reported to medtronic neurosurgery. The products were unavailable for return. Therefore an evaluation of device performance was not possible. A review of the manufacturing records was not possible as no lot numbers were provided. All catheters are 100% inspected at the time of manufacture. Literature article: hemorrhagic complications of ventriculostomy: incidence and predictors in patients with intracerebral hemorrhage authors: eric s. Sussman, b. S. , christopher p. Kellner, m. D. , eric nelson, b. A. , michael m. Mcdowell, b. S. , samuel s. Bruce, m. A. , rachel a. Bruce, b. A. , zong zhuang, b. S. , and e. Sander connolly jr. , m. D. J neurosurg 120:931¿936, 2014. Http://thejns. Org/doi/abs/10. 3171/2013. 12. Jns131685.
 
Event Description
Medtronic neurosurgery identified the following information upon review of scientific literature: a total of 22 patients experienced post ventriculostomy hemorrhage. The article noted that intraparenchymal hemorrhage occurred in 19 of these 22 patients, subarachnoid hemorrhage in 3, subdural hemorrhage in 1 and epidural hemorrhage in 1. Reportedly, 1 patient experienced simultaneous intraparenchymal and subdural hemorrhages, and 1 patient had both intraparenchymal and subarachnoid hemorrhages. The article stated that the majority of these bleeds were small and subclinical. The article also stated that post ventriculostomy hemorrhage was clinically significant in only 1 patient; the location of the bleed in this patient was epidural. According to the article, patients treated with smaller-diameter catheters had a significantly greater mean hemorrhage volume than patients treated with larger-diameter catheters.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
bob shokoohi
125 cremona drive
goleta, CA 93117
8055718725
MDR Report Key6030716
MDR Text Key57483618
Report Number2021898-2016-00371
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 literature
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/16/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/14/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received09/16/2016
Was Device Evaluated by Manufacturer? No
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: 10/14/2016 Patient Sequence Number: 1
-
-