MAUDE Adverse Event Report: MEDTRONIC MEDTRONIC REVEAL LINQ

Model Number RLA693266S

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Atrial Fibrillation (1729)

Event Date 06/15/2016

Event Type  Injury  

Event Description

Device was implanted for suspected atrial fibrillation.The pt had episodes of palpitations and was admitted for rapid atrial fibrillation, but the device did not record any of those episodes.

• Brand Name: MEDTRONIC REVEAL LINQ
• Type of Device: LINQ
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 5754545
• MDR Text Key: 48420310
• Report Number: MW5063087
• Device Sequence Number: 1
• Product Code: DSI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/16/2016

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: Lay User/Patient
• Device Model Number: RLA693266S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/24/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 58 YR
• Patient Weight: 82