MAUDE Adverse Event Report: COVIDIEN LP - SUPERDIMENSION INC UNKNOWN EMPRINT ANTENNA; SYSTEM, IMAGE PROCESSING, RADIOLOGICAL

Model Number UNKNOWN EMPRINT ANTENNA

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

Patient Problem Insufficient Information (4580)

Event Date 10/05/2022

Event Type  malfunction  

Event Description

According to the literature, a retrospective study was conducted to quantify tumor and liver shrinkage after mwa using jd mapping and assess patient and tumor specific factors that may affect the extent of tissue shrinkage.Between (b)(6) 2012 and (b)(6) 2021 there were 24 patients included in the study and postoperative complications included a local hematoma which was treated conservatively.Another patient underwent liver transplantation shortly after mwa.It is unknown if the device contributed to the need for a liver transplant.

Manufacturer Narrative

Title: evaluation of tissue shrinkage after ct-guided microwave ablation in patients with liver malignancies using jacobian determinant source: international journal of hyperthermia, issn: (print) (online) journal homepage: https://www.Tandfonline.Com/loi/ihyt20, 39:1, 1371-1378, doi: 10.1080/02656736.2022.2134593 published online: 20 oct 2022 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 Description

According to the literature, a retrospective study was conducted to quantify tumor and liver shrinkage after mwa using jd mapping and assess patient and tumor specific factors that may affect the extent of tissue shrinkage.Between december 2012 and february 2021 there were 24 patients included in the study.Another patient underwent liver transplantation shortly after mwa.It is unknown if the device contributed to the need for a liver transplant.

Manufacturer Narrative

This event has been reassessed and the reportability has been determined to be a serious injury.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: UNKNOWN EMPRINT ANTENNA
• Type of Device: SYSTEM, IMAGE PROCESSING, RADIOLOGICAL
• Manufacturer (Section D): COVIDIEN LP - SUPERDIMENSION INC; 161 cheshire lane, suite 100; plymouth MN 55441
• Manufacturer (Section G): COVIDIEN LP - SUPERDIMENSION INC; 161 cheshire lane, suite 100; plymouth MN 55441
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 16119317
• MDR Text Key: 308924184
• Report Number: 3004962788-2023-00002
• Device Sequence Number: 1
• Product Code: LLZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN EMPRINT ANTENNA
• Device Catalogue Number: UNKNOWN EMPRINT ANTENNA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2022
• Initial Date FDA Received: 01/08/2023
• Supplement Dates Manufacturer Received: 01/06/2023
• Supplement Dates FDA Received: 01/27/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention