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

Model Number LMM-GENERAL

Device Problems Output Problem (3005); Data Problem (3196)

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

Event Date 01/19/2022

Event Type  malfunction  

Event Description

It was reported that during the post-implantation check, the implantable cardiac monitor (icm) electrocardiogram (ecg) waveform displayed by the diagnostic mobile programmer application was fluctuating, with no ventricular sensing (vs) markers displayed.It was considered that the icm was under-sensing.A legacy programmer was then used and the issue did not recur with the implant procedure completed without further issue.The diagnostic mobile programmer application remains in use.No patient complications have been reported as a result of this event.

Manufacturer Narrative

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

• 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: 13450789
• MDR Text Key: 285046179
• Report Number: 2182208-2022-00364
• 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: 02/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2022
• 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
• Date Manufacturer Received: 01/19/2022
• 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
• Treatment: LNQ11 IMPLANTABLE CARDIAC MONITOR (ICM)
• Patient Age: 69 YR
• Patient Sex: Male