• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

IPG MFG SWITZERLAND REVEAL LINQ DETECTOR AND ALARM, ARRHYTHMIA Back to Search Results
Model Number LNQ11
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Wound Dehiscence (1154); Pain (1994)
Event Date 11/20/2014
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

It was reported that the patient presented to the er due to having pain at the site of their implantable cardiac monitor (icm) implant. The patient had developed wound dehiscence and the device had migrated. The device was removed. No further patient complications have been reported as a result of this event.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameREVEAL LINQ
Type of DeviceDETECTOR 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 Key5425377
MDR Text Key37926514
Report Number9614453-2016-01307
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK132649
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 12/03/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/09/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/28/2015
Device MODEL NumberLNQ11
Device Catalogue NumberLNQ11
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/03/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured10/10/2014
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 02/09/2016 Patient Sequence Number: 1
-
-