MAUDE Adverse Event Report: MEDTRONIC, INC. CARELINK SMARTSYNC PLATFORM (IOS); ANALYZER, PACEMAKER GENERATOR FUNCTION

Model Number M01A01

Device Problems Computer Operating System Problem (2898); Data Problem (3196)

Patient Problem No Patient Involvement (2645)

Event Date 07/28/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the programmer software on the tablet froze and became unresponsive, after saving a final report and choosing to share the file.The issue occurred on multiple occasions and sometimes displayed a white screen.To resolve the issue the application required a shut down and restart which in turn wiped all testing data.The programmer remains in use.There was no patient involvement.

Manufacturer Narrative

Data logs were reviewed.Instrument certificate server errors were found that do not allow the base or radiofrequency head to proceed further even if the instruments are valid before.It was not clear that these errors related to the observation that the programmer software on the tablet froze and became unresponsive after saving a final report and choosing to share the file.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 PLATFORM (IOS)
• Type of Device: ANALYZER, PACEMAKER GENERATOR FUNCTION
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 10400955
• MDR Text Key: 202701495
• Report Number: 2182208-2020-01507
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M01A01
• Device Catalogue Number: M01A01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PROGRAMMER 24970A; PROGRAMMER 24970A