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

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.

• 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: 13113086
• MDR Text Key: 282966218
• Report Number: 9612501-2021-02174
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 00763000027261
• UDI-Public: 00763000027261
• 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,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 Received: 12/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 42866
• Device Catalogue Number: 42866
• Device Lot Number: 0222024315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2021
• 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