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

Model Number	27816
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient information was unavailable 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 or Problem Description
Medtronic received information regarding a strata device.It was reported that it was broken.On (b)(6) 2022 the patient had a revision surgery due to the shunt being damaged.The "snap" that should be on the left side of the shunt was on the right.There was history of clinical deterioration for some months and x-ray picture shows interruption at the "snap" part.The reported issue occurred during normal use since the shunt had been in use since 2018.There was no reported impact to the patient after the revision surgery.The patient did received another medtronic device.The procedure was a shunt implant on mph-diagnosis.
Additional Manufacturer Narrative
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.
Event or Problem Description
It was stated that the shunt broke in (b)(4) pieces the snap and the shunt house.The shunt had been implanted sine 2018.The issue did not occur during a procedure.The shunt was in (b)(4) pieces when the health care professional performed a revision of the shunt.Due to lack of treatment of the patient.The patient is doing much better, but not back to normal like after the initial implant in 2018.There was no reported impact to the patient during the revision procedure.There was no reported delay to the revision procedure.

• Brand Name: STRATA®
• Common Device Name: 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: 14117468
• Report Number: 9612501-2022-00568
• Device Sequence Number: 2428172
• Product Code: JXG
• UDI-Device Identifier: 00643169975606
• UDI-Public: 00643169975606
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K042465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: 27816
• Device Catalogue Number: 27816
• Device Lot Number: E48952
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2022
• Supplement Date Received by Manufacturer: 07/26/2022
• Initial Report FDA Received Date: 04/15/2022
• Supplement Report FDA Received Date: 07/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/17/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown