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

Model Number LMM-GENERAL

Device Problem Device Difficult to Program or Calibrate (1496)

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

Event Date 12/13/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that at the patient's follow up appointment, following an implant procedure using the diagnostic mobile programmer application which was performed three months prior that it was noted that the implantable cardiac monitor (icm) had not been activated and detections were not on.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 SINGAPORE OPERATIONS; 49 changi south avenue 2; nasaco tech centre; singapore 48605 6; SN 486056
• Manufacturer (Section G): MEDTRONIC SINGAPORE OPERATIONS; 49 changi south avenue 2; nasaco tech centre; singapore 48605 6; SN 486056
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 13710595
• MDR Text Key: 286869208
• Report Number: 3008973940-2022-01023
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 03/09/2022

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: 02/22/2022
• Initial Date FDA Received: 03/09/2022
• 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 Sex: Male