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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 Mechanics Altered (2984)
Patient Problem No Known Impact Or Consequence To Patient (2692)
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 valve setting was changing on the patient multiple times. The surgeon noted that they would not be surprised if the patient was ¿messing with it¿ and changed the setting. The valve was explanted and they wanted it analyzed.
 
Manufacturer Narrative
The returned valve was patent. The valve met the requirements of the reflux, siphon, and valve flux testing. It did not meet the requirements for leak, pressure-flow and preimplantation testing. The valve did not spontaneously change levels during the course of analysis; therefore, the complaint could not be reproduced by the laboratory technicians. The valve did not meet the requirements for leak testing due to a tear/cut in the casing of the delta chamber. There was also damage on the flange. It is unknown how or when this damage occurred. The ifu cautions that, ¿improper use of instruments in the handling or implantation of shunt products may result in the cutting, slitting or crushing of components. Such damage may lead to loss of shunt integrity. ¿ there was proteinaceous debris observed on the interior and exterior of the valve. The ifu cautions that, ¿care must be taken to ensure that particulate contaminants are not introduced into shunt components during preimplantation testing or handling. Introduction of contaminants could result in improper performance of the shunt system. ¿ all valves are 100% tested at the time of manufacture. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received reported that it was unknown if the patient had been around sources of magnetic interference.
 
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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 Key8067032
MDR Text Key127048683
Report Number2021898-2018-00529
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 12/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2018
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? Device Returned to Manufacturer
Date Returned to Manufacturer12/04/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/13/2018
Was Device Evaluated by Manufacturer? Yes
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: 11/13/2018 Patient Sequence Number: 1
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