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

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.

• Brand Name: STRATA®
• Type of Device: SHUNT, 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 Key: 13932985
• MDR Text Key: 288320897
• Report Number: 9612501-2022-00483
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K042465
• Number of Events Reported: 1
• 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 Received: 03/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 27819
• Device Catalogue Number: 27819
• Device Lot Number: 0222615245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2022
• Date Manufacturer Received: 03/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male