MAUDE Adverse Event Report: MEDTRONIC, INC. 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 04/09/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that after an implant using the diagnostic mobile programmer application (lmm), the patient was asked to do a manual recording.The device was interrogated and indicated the recording was in progress and the session was ended.Several days later, the patient sent a manual transmission from home showing a pause, the hospital noted that there was no automatic recording showing.The automatic recording was not active so the patient returned back to the facility to have them re-programmed off.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: 11731757
• MDR Text Key: 247494729
• Report Number: 2182208-2021-01695
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2021
• 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: 04/15/2021
• 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