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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY UNKNOWN STRATA VALVE/SHUNT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

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MEDTRONIC NEUROSURGERY UNKNOWN STRATA VALVE/SHUNT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number UNKNOWN-S
Device Problem Inaccurate Flow Rate (1249)
Patient Problem Hemorrhage, Subdural (1894)
Event Date 10/16/2017
Event Type  Injury  
Manufacturer Narrative
Patient information provided. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received reported the patient had ¿no other surgeries after. ¿ it was not clear if this referred to the previously reported operation needed to ligate the shunt tubing.
 
Manufacturer Narrative
Event date is an approximation. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that within the last 2-4 months, the physician had been treating the patient for a subdural hematoma due to overdrainage. It was stated the physician had turned the valve up to 2. 5. Usually, the physician said that high of a setting helped to stop the progression of the subdural, but in this instance, they had to operate and ligate the shunt tubing to stop cerebrospinal fluid flow completely. The shunt remained implanted in this patient.
 
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Brand NameUNKNOWN STRATA VALVE/SHUNT
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 Key7130694
MDR Text Key106384672
Report Number2021898-2017-00658
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 health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN-S
Device Catalogue NumberUNKNOWN-S
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 Received04/24/2018
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: 12/19/2017 Patient Sequence Number: 1
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