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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 No Known Impact Or Consequence To Patient (2692)
Event Date 07/29/2016
Event Type  malfunction  
Manufacturer Narrative
The product was unavailable for return. Therefore an evaluation of the device performance was not possible. A review of the manufacturing records showed no anomalies. All valves are 100% tested at the time of manufacture.
 
Event Description
It was reported to medtronic neurosurgery that the device was not working properly. According to the report, when the device was placed into the patient there was no flow coming out of the device intraoperatively. Reportedly, flow from the device was observed only when the doctor pumped the device. The report stated the doctor replaced the device with a new device that was working properly. Reportedly, there was no injury to the patient and the patient is doing well.
 
Manufacturer Narrative
The returned valve was patent and met the requirements for reflux, siphon, pressure flow, preimplantation 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.
 
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
bob shokoohi
125 cremona drive
goleta, CA 93117
8055718725
MDR Report Key5908680
MDR Text Key53290080
Report Number2021898-2016-00302
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
Report Date 07/29/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/26/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2019
Device Catalogue Number42866
Device Lot NumberE09896
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/07/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/05/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/18/2016
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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