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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY STRATA II SHUNT ASSEMBLY, WITH BIOGLIDE SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

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MEDTRONIC NEUROSURGERY STRATA II SHUNT ASSEMBLY, WITH BIOGLIDE SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Catalog Number 27819
Device Problem Inaccurate Flow Rate (1249)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/17/2016
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. All catheters are 100% inspected at the time of manufacture.
 
Event Description
It was reported to medtronic neurosurgery that the cerebrospinal fluid did not flow normally with setting pressure prior to use. According to the report, the device was replaced with a new device to complete the surgery and there was no patient impact.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand NameSTRATA II SHUNT ASSEMBLY, WITH BIOGLIDE
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 Key6179635
MDR Text Key62532387
Report Number2021898-2016-00478
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K042465
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/17/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/15/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2018
Device Catalogue Number27819
Device Lot NumberE09184
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 Received11/17/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/19/2016
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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