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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LLC STRATA® SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

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COVIDIEN LLC STRATA® SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number 42866
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 12/08/2021
Event Type  Injury  
Manufacturer Narrative
Patient age not available from the site. Patient weight not available from the site. No parts have been received by the manufacturer for evaluation. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a strata valve being used in a hydrocephalus procedure. It was reported that the patient received a shunt valve implant. After the procedure, there was redness and swelling at the valve position which turned into a ruptured and infection. The health care professional doubted whether the material of the shunt tube caused the allergy.
 
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Brand NameSTRATA®
Type of DeviceSHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
Manufacturer (Section D)
COVIDIEN LLC
15 hampshire street
mansfield 02048
Manufacturer (Section G)
COVIDIEN LLC
15 hampshire street
mansfield 02048
Manufacturer Contact
glen belmer
9775 toledo way
irvine, CA 92618
6122713209
MDR Report Key13113086
MDR Text Key282966218
Report Number9612501-2021-02174
Device Sequence Number1
Product Code JXG
UDI-Device Identifier00763000027261
UDI-Public00763000027261
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K042465
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number42866
Device Catalogue Number42866
Device Lot Number0222024315
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/11/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/14/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/29/2021 Patient Sequence Number: 1
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