MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER VALLEYLAB FT10; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number VLFT10GEN

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

Patient Problems Unspecified Heart Problem (4454); Unspecified Tissue Injury (4559)

Event Date 11/13/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 60sf2, cryo acc 60sf2 cryocath surgifrost (serial#: (b)(4); r65cs1, console r65cs1 cryoflex (serial#:(b)(4); 49341, clamp 49341 cardioblate lp ft (serial#: (b)(4); (lot#: 631e).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.

Event Description

According to the reporter, patient had a tachybradycardia.A sinus rhythm with first-degree av block for a period of time was noted for a period of time.The patient continued to have intermittent periods of junctional rhythm.Ep was consulted.Patient underwent a permanent pacemaker medtronic dual-chamber with left bundle branch are pacing.There were no intraprocedural complications.Surgeon have not seen sinus node function since surgery.Noted on day 5 post-op.Sinus node was possible injured during the surgery.Postoperatively, the patient had been in junctional rhythm rate of 40s to 50s with occasional rare sinus beat.Adverse event possibly related to concomitant procedure and study device.

Event Description

According to the reporter, the patient had sick sinus syndrome.A sinus rhythm with first-degree av block was noted for a period of time.The patient continued to have intermittent periods of junctional rhythm.Ep was consulted.Patient underwent a permanent pacemaker medtronic dual-chamber with left bundle branch are pacing.There were no intraprocedural complications.The surgeon has not seen sinus node function since surgery.Noted on day 5 post-op.Sinus node was possible injured during the surgery.Postoperatively, the patient had been in junctional rhythm rate of 40s to 50s with occasional rare sinus beat.Adverse event possibly related to concomitant procedure, study procedure and study device.The patient was recovered/resolved on (b)(6) 2022.

Manufacturer Narrative

Additional information: b5, g3 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: VALLEYLAB FT10
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer (Section G): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 15919692
• MDR Text Key: 304844092
• Report Number: 1717344-2022-01490
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884521516328
• UDI-Public: 10884521516328
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VLFT10GEN
• Device Catalogue Number: VLFT10GEN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2023
• 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): Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White