MAUDE Adverse Event Report: MEDTRONIC, INC. PATIENT CONNECTOR; DETECTOR AND ALARM, ARRHYTHMIA

Model Number 24967

Device Problems Display or Visual Feedback Problem (1184); Communication or Transmission Problem (2896)

Patient Problem Asystole (4442)

Event Date 07/12/2021

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 patient connector and the tablet operating system continuously lost connection during the testing of the device in the patient pocket.It was noted that it was a new right ventricular (rv) lead procedure in a pacing dependent patient and upon connection of the new lead to the new can there was a loss of capture and an asystole that lasted for numerous seconds.Troubleshooting steps were taken to restore the connection but the issue persisted.It was noted that error messages were displayed that indicated that the test was not confirmed and the user was unable to complete the tests in a timely manner.It was noted that the loss of connection occurred a large number of times and testing of the lead only occurred outside of the operating theatre and the user was able to assure lead stability.The programmer remains in use.No further patient complications were reported as a result of the event.

Manufacturer Narrative

The device was not returned for analysis, however performance data collected from the device was reviewed.It was reported that the bluetooth connection was lost while using the mobile programmer application and there was an issue with diagnostic messaging.This complaint was confirmed based on log files.Analysis of the mobile application logs indicated that bluetooth connectivity dropped out.The most likely root cause was traced to a known inherent risk of the device.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.

Manufacturer Narrative

Further analysis of the mobile application logs indicated the common application had incorrect data.The customer comment was complaint was confirmed based on log files.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.

Manufacturer Narrative

This report is being submitted as part of a retrospective review and remediation for capa 564121 per (b)(4).A correction is being submitted for an update to b1, b2, and h1.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: PATIENT CONNECTOR
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 12305946
• MDR Text Key: 265967890
• Report Number: 2182208-2021-03141
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P890003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24967
• Device Catalogue Number: 24967
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2024
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: 24967 PATIENT CONNECTOR, 5076-58 LEAD; 24967 PATIENT CONNECTOR, 5076-58 LEAD
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 67 YR
• Patient Sex: Female