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

Model Number LNQ11

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Hematoma (1884)

Event Date 11/27/2018

Event Type  Injury  

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) patient experienced a haematoma of the right and left breast after implantation of the device.The patient was treated with an infusion.The icm remains in use.The patient is a participant in the symplicity af study.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

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

Event Description

It was further reported that the hematoma is most probably due to anti-coagulation subscribed for icm implant procedure.

• Brand Name: REVEAL LINQ
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): MEDTRONIC SINGAPORE OPERATIONS; 49 changi south avenue 2; nasaco tech centre; singapore MN 48605 6; SG 486056
• Manufacturer (Section G): MEDTRONIC SINGAPORE OPERATIONS; 49 changi south avenue 2; nasaco tech centre; singapore MN 48605 6; SG 486056
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 8173053
• MDR Text Key: 130615334
• Report Number: 2182208-2018-02268
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K132649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/14/2019
• Device Model Number: LNQ11
• Device Catalogue Number: LNQ11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2018
• Date Device Manufactured: 09/20/2018
• 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): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 75