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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
Catalog Number UNKNOWN-S
Device Problem Inaccurate Flow Rate (1249)
Patient Problems Headache (1880); Coma (2417)
Event Date 01/01/2016
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 was not possible as no lot number was provided. All valves are 100% tested at the time of manufacture. All catheters are 100% inspected at the time of manufacture. (b)(4).
 
Event Description
It was reported to medtronic neurosurgery that the patient was implanted with the shunt due to hydrocephalus in (b)(6) 2015. According to the report in (b)(6) 2016, the patient was in the hospital for observation and was in a coma. It was reported the catheter had poor drainage and there was too much cerebrospinal fluid. Reportedly, the patient is now conscious, but is experiencing headaches.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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
jeffrey henderson
125 cremona drive
goleta, CA 93117
8055718445
MDR Report Key5453981
MDR Text Key38785424
Report Number2021898-2016-00070
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign
Reporter Occupation Patient Family Member or Friend
Type of Report Initial,Followup
Report Date 01/25/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN-S
Device Lot NumberUNKNOWN
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 Received01/25/2016
Was Device Evaluated by Manufacturer? No
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: 02/23/2016 Patient Sequence Number: 1
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