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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 Problem Appropriate Term/Code Not Available (3191)
Patient Problem Therapeutic Response, Decreased (2271)
Event Date 11/01/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported the patient fell and hit their head in late (b)(6) 2018. Following that, the patient¿s hydrocephalus symptoms deteriorated, and the patient visited the hospital. After checking the valve with a stratavarius, it was identified that the pressure setting was changed. It was confirmed that the stratavarius could adjust the valve to all settings. In addition, the shunt system¿s patency was identified by contrast. Both the valve and peritoneal catheter was replaced. The distal end of the catheter was occluded. The patency of the valve was confirmed, but analysis of the valve was still requested.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received reported the catheter was implanted over two years prior.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received reported that after replacing the valve and peritoneal catheter, the progress of the patient was good. It was stated that a foreign body was formed at the end of the peritoneal catheter so it was probably the cause of the occlusion. However, because the patient fell down and the valve was hit strongly, analysis on whether the valve was broken was requested.
 
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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 Key8201062
MDR Text Key131585538
Report Number2021898-2018-00592
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2018
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 Received01/15/2019
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: 12/27/2018 Patient Sequence Number: 1
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