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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 07/22/2016
Event Type  malfunction  
Manufacturer Narrative
The product was unavailable for return as it was discarded at the facility. 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 found to not be draining properly. Reportedly, it wasn't flowing distally intraoperatively. According to the report, the doctor replaced the device with another device to complete the surgery successfully. Reportedly, there was no injury to the patient.
 
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 Key5905309
MDR Text Key53039556
Report Number2021898-2016-00298
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
Report Date 07/26/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/25/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2018
Device Catalogue Number42866
Device Lot NumberE02613
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/26/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/14/2015
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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