MAUDE Adverse Event Report: IPG MFG SWITZERLAND REVEAL LINQ; DETECTOR AND ALARM, ARRHYTHMIA

Model Number LNQ11

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Itching Sensation (1943); Pain (1994)

Event Date 11/17/2015

Event Type  Injury  

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.(b)(4).

Event Description

The patient reported pain and pressure at the implantable cardiac monitor (icm) implant site.They stated that part of the icm was below the incision and part was above and that the site was red and itching.The following physician confirmed that the monitor was sticking out of the incision but showed no signs of infection.The icm was removed and a new device was later implanted.No patient complications have been reported as a result of this event.

• Brand Name: REVEAL LINQ
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): IPG MFG SWITZERLAND; route du molliau 31; tolochenaz 1131 ; CH 1131
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM HEART FAILURE; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 5481310
• MDR Text Key: 39739993
• Report Number: 9614453-2016-01618
• Device Sequence Number: 1
• Product Code: DSI
• 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: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/14/2016
• Device Model Number: LNQ11
• Device Catalogue Number: LNQ11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/24/2015
• Date Device Manufactured: 07/15/2015
• 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): Hospitalization; Required Intervention
• Patient Age: 00039 YR