MAUDE Adverse Event Report: MEDTRONIC, INC. REVEAL LINQ MOBILE MANAGER APP; DETECTOR AND ALARM, ARRHYTHMIA

Model Number LMM-GENERAL

Device Problems Computer Software Problem (1112); Output Problem (3005); Data Problem (3196)

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

Event Date 12/28/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that when the diagnostic mobile programmer application was used in an implant procedure the electrocardiogram displayed was unstable and the ventricular sensing (vs) marker was not displayed.It was noted that although the patient was at rest, the waveforms moved up and down greatly and there were also some areas where the gain was changed and the waveform could not be received so the vs marker was not displayed.A legacy programmer was then used and the issue did not recur with the implant procedure completed without further issue.It was further noted that the user observed with the diagnostic mobile programmer application that it was difficult to determine whether the placement position was correct (whether or not the waveforms were firmly observed), so it was discussed whether or not to re-implant after extraction.The displayed rate appeared to be stable for each heart rate (it did not seem like it was under 50's).It was further noted that the patient connector was on the patient and the device check was performed within 1 metre of the side of the patient.No patient complications have been reported as a result of this event.

• Brand Name: REVEAL LINQ MOBILE MANAGER APP
• 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: 13358001
• MDR Text Key: 284462861
• Report Number: 2182208-2022-00244
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K150614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LMM-GENERAL
• Device Catalogue Number: LMM-GENERAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/28/2021
• Initial Date FDA Received: 01/26/2022
• 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
• Patient Sex: Male