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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY STEPDOWN CONNECTOR WITH TUBING SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

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MEDTRONIC NEUROSURGERY STEPDOWN CONNECTOR WITH TUBING SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number 22063
Device Problem Inaccurate Flow Rate (1249)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/02/2017
Event Type  malfunction  
Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was that during the procedure, fluid such as cerebrospinal fluid (csf) did not drain smoothly when pumping was performed using csf and saline. Therefore, the use of the devices were discontinued. Per the physician, the flow back from the reservoir was slow and discharge of the csf could not be observed. As further difficulties were expected in checking the device operation once they were placed subcutaneously, the use of the devices were discontinued. After implanting a part of the lumbar catheter in the patient, a backup lumbar peritoneal (lp) shunt was unpacked and connected with the lumbar catheter and lp valve, and further connected with the lp shunt. It was noted that the proximal edge of the lumbar catheter had remained inside the patient's body. The distal edge was explanted.
 
Manufacturer Narrative
The returned stepdown connector was patent, and met the requirements for leak testing. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameSTEPDOWN CONNECTOR WITH TUBING
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 Key7068927
MDR Text Key93501745
Report Number2021898-2017-00614
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K862303
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/29/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2021
Device Model Number22063
Device Catalogue Number22063
Device Lot NumberE15629
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/27/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/21/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/28/2016
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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