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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY STRATAMR VALVE, SMALL SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

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MEDTRONIC NEUROSURGERY STRATAMR VALVE, SMALL SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Catalog Number 42955
Device Problem Inaccurate Flow Rate (1249)
Patient Problem Therapeutic Response, Decreased (2271)
Event Date 08/02/2016
Event Type  Injury  
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 patient was implanted with the device on (b)(6) 2016. According to the report, the patient became symptomatic. The report stated that the device was found to have a flow issue. It was reported that the device was explanted on (b)(6) 2016.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand NameSTRATAMR VALVE, SMALL
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 Key5916175
MDR Text Key53545401
Report Number2021898-2016-00306
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K152700
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 08/02/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2019
Device Catalogue Number42955
Device Lot NumberE13483
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 Received08/02/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/19/2016
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: 08/30/2016 Patient Sequence Number: 1
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