MAUDE Adverse Event Report: UNKNOWN FOTA SFTWR; MEDICAL DEVICE DATA SYSTEM

Model Number UNK_FOTASOFTWARE

Device Problems Appropriate Term/Code Not Available (3191); Wireless Communication Problem (3283)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/30/2024

Event Type  malfunction  

Manufacturer Narrative

Select patient information cannot be provided due to regional privacy regulations.Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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

Information received by medtronic indicated that the customer reported cannot open the carelink uploader on the computer.Troubleshooting was performed customer was able to reinstall uploader and the issue was not resolved.No harm requiring medical intervention was reported.The customer will continue using the device and the device will not be returned for analysis.

• Brand Name: UNKNOWN FOTA SFTWR
• Type of Device: MEDICAL DEVICE DATA SYSTEM
• MDR Report Key: 18719379
• MDR Text Key: 335556292
• Report Number: 2032227-2024-127027
• Device Sequence Number: 1
• Product Code: OUG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Type of Report: Initial
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UNK_FOTASOFTWARE
• Device Catalogue Number: UNK_FOTASOFTWARE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/30/2024
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 52 YR