MAUDE Adverse Event Report: MEDTRONIC INC. CARELINK SMARTSYNC BASE; ANALYZER, PACEMAKER GENERATOR FUNCTION

Model Number 24970A

Device Problems Display or Visual Feedback Problem (1184); Pacing Problem (1439)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/14/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during use of the analyzer of the mobile programmer it was sluggish and an error was generated indicating that the application needed to be closed and that the user should contact a company representative.It was noted that when trying to do a threshold test the user could not decrement the outputs and was stuck pacing at 90 beats per minute.It was further noted that while trying to analyze the implantable device the user could not select the mode or change the rate back down from 90 beats per minute.The mobile programmer was changed out for a non-mobile programmer to use its analyzer that was present as a back up to resolve the issue.The mobile programmer remains in use.No patient complications have been reported as a result of this event.

Manufacturer Narrative

The device was not returned for analysis.However, performance data collected from the device was received and analyzed.Analysis of the device memory was performed and it was found that issue of application crashing when navigated away from date screen post-changing date in patient information in certain operating system versions was a known issue related to an existing released product investigation (rpi).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: CARELINK SMARTSYNC BASE
• Type of Device: ANALYZER, PACEMAKER GENERATOR FUNCTION
• Manufacturer (Section D): MEDTRONIC INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 10585760
• MDR Text Key: 208506300
• Report Number: 3004593495-2020-01130
• Device Sequence Number: 1
• Product Code: DTC
• Combination Product (y/n): N
• PMA/PMN Number: P890003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 24970A
• Device Catalogue Number: 24970A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1