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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 27819
Device Problems Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problem Unspecified Infection (1930)
Event Date 03/03/2022
Event Type  Injury  
Manufacturer Narrative
Patient age not available from the site. Patient weight not available from the site. The shunt was returned to the manufacture for evaluation. The complaint reports that after the shunt was implanted, an infection occurred. Due to the use of the same sterilization equipment and nature of pressurized testing for valves and catheters, the device will not be decontaminated or tested in the pe lab to accommodate laboratory personnel safety. The device has been discarded. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a shunt and catheter being used in a procedure. It was reported that after the shunt and catheter were implanted, there was a postoperative infection that occurred. The drainage was not smooth and multiple pressure adjustments occurred. The site stated that after the shunt and catheter were implanted, the patient developed an infection, the shunt was not smooth, and the pressure was adjusted several times in the middle, but it was ineffective. Additional information was received stating that medication was provided to the patient to help with the infection. Both the shunt and the catheter were replaced. The patient has now recovered from the infection.
 
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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 Key13932985
MDR Text Key288320897
Report Number9612501-2022-00483
Device Sequence Number1
Product Code JXG
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,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/28/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number27819
Device Catalogue Number27819
Device Lot Number0222615245
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/17/2022
Date Manufacturer Received03/03/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/27/2021
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: 03/28/2022 Patient Sequence Number: 1
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