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

Model Number LNQ11

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Blood Loss (2597)

Event Date 03/08/2017

Event Type  Death  

Event Description

It was reported that the patient's family stated that the patient passed away due to the incision site bleeding profusely post-implant.It was further reported that the night of implant the incision site of the implantable cardiac monitor (icm) incision site was bleeding ¿profusely¿ and the patient was taken to the emergency room.The patient was reported to have been taking a blood thinner.The patient was transferred to another facility, no further surgery was performed due to the patient¿s wishes.The patient was discharged from the hospital very weak and passed away a week later.Additional information related to the patient¿s death have been requested and not received.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.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: 6465278
• MDR Text Key: 71922929
• Report Number: 9614453-2017-00930
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00643169732216
• UDI-Public: 00643169732216
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/28/2018
• Device Model Number: LNQ11
• Device Catalogue Number: LNQ11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/27/2017
• Initial Date FDA Received: 04/06/2017
• Supplement Dates Manufacturer Received: 03/27/2017
• Supplement Dates FDA Received: 10/02/2017
• Date Device Manufactured: 01/31/2017
• 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
• Patient Outcome(s): Death
• Patient Age: 92 YR