MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL REVEAL LINQ; DETECTOR AND ALARM, ARRHYTHMIA

Model Number LNQ11

Device Problem Device-Device Incompatibility (2919)

Patient Problem No Patient Involvement (2645)

Event Date 03/22/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the implantable cardiac monitor (icm) could not be pre-programmed before implant.A different icm was implanted.No patient involvement or complications were reported as a result of this event.

Manufacturer Narrative

Product event summary: the device was returned and analyzed.Returned product analysis was performed and no anomalies were found.If information is provided in the future, a supplemental report will be issued.

• Brand Name: REVEAL LINQ
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; CH 1131
• Manufacturer (Section G): MEDTRONIC EUROPE SARL; route du molliau 31; case postale; tolochenaz vaud 1131 ; CH 1131
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7459738
• MDR Text Key: 106650520
• Report Number: 9614453-2018-01365
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00643169845749
• UDI-Public: 00643169845749
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/15/2018

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 Expiration Date: 08/28/2018
• Device Model Number: LNQ11
• Device Catalogue Number: LNQ11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2018
• Initial Date FDA Received: 04/25/2018
• Supplement Dates Manufacturer Received: 05/15/2018
• Supplement Dates FDA Received: 05/15/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/12/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1