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U.S. Department of Health and Human Services

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

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MEDTRONIC NEUROSURGERY STRATA II VALVE, REGULAR SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Catalog Number 42866
Device Problem Inaccurate Flow Rate (1249)
Patient Problem Therapeutic Response, Decreased (2271)
Event Date 02/05/2016
Event Type  Injury  
Manufacturer Narrative
The returned valve was patent. The valve met the requirements for siphon, reflux, pressure-flow, pre-implantation, and leak testing. Therefore the conditions of the complaint could not be duplicated by laboratory personnel. A review of the manufacturing records was not possible as no lot number was provided. All valves are 100% tested at the time of manufacture. (b)(4).
 
Event Description
It was reported to medtronic neurosurgery that the device was not doing well with the patient. According to the report the device was found to not be draining enough. The report stated the pressure level settings were adjusted, but that did not make a difference. It was reported the device was explanted on (b)(6) 2016 and replaced with another strata valve. Reportedly, there was no injury to the patient.
 
Manufacturer Narrative
The returned valve was patent. The valve met the requirements for siphon, reflux, pressure-flow, pre-implantation, and leak testing. Therefore the conditions of the complaint could not be duplicated by laboratory personnel. A review of the manufacturing records was not possible as no lot number was provided. All valves are 100% tested at the time of manufacture. Additional patient/device information: the patient's initials, age, and gender were provided. The date of implant and explant were provided. The lot number of the device was also reported.
 
Manufacturer Narrative
The returned valve was patent. The valve met the requirements for siphon, reflux, pressure-flow, pre-implantation, and leak testing. Therefore, the conditions of the complaint could not be duplicated by laboratory personnel. A review of the manufacturing records showed no anomalies. All valves are 100% tested at the time of manufacture. Additional patient/device information: the patient's initials, age, and gender were provided. The date of implant and explant were provided. The lot number of the device was also reported. Correction: a review of the manufacturing records was performed and showed no anomalies.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand NameSTRATA II VALVE, REGULAR
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
jeffrey henderson
125 cremona drive
goleta, CA 93117
8055718445
MDR Report Key5480323
MDR Text Key39675443
Report Number2021898-2016-00087
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K042465
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 02/05/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2017
Device Catalogue Number42866
Device Lot NumberD69630
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/17/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/14/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/08/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/04/2016 Patient Sequence Number: 1
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