MAUDE Adverse Event Report: COVIDIEN LLC STRATA II SHUNT ASSEMBLY, SMALL, WITH BIOGLIDE; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number 27818

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Headache (1880); Unspecified Infection (1930)

Event Date 10/16/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the shunt seemed to be working for the first 7 days.Then, the patient was complaining of a headache.An x-ray was taken, and the picture showed a suspected abscess in the brain around the ventricular catheter.The wound did not look very nice; however, there was no pus coming from the wound.It was noted that when implanting the ventricular catheter, there was no bleeding or oozing blood from the burr hole.The whole shunt was removed, and the patient now lived without a shunt.The patient received intravenous and oral antibiotics.

Manufacturer Narrative

The returned valve was patent.The valve met the requirements for leakage, valve flux testing, siphon control, reflux, pressure/flow and pre-implantation testing.The catheter returned with the valve was also patent and passed leakage testing requirements.The failure observed in the field could not be replicated by the laboratory personnel.Review of dhr for lot # 0219127878 did not indicate any anomalies associated with the failure observed in the field.All valves are 100% tested at the time of manufacture.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: STRATA II SHUNT ASSEMBLY, SMALL, WITH BIOGLIDE
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire street; mansfield 02048
• MDR Report Key: 10721455
• MDR Text Key: 212587774
• Report Number: 9612501-2020-01516
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K042465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 01/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/25/2022
• Device Model Number: 27818
• Device Catalogue Number: 27818
• Device Lot Number: 0219127878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2020
• Date Manufacturer Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR