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

Model Number LNQ11

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

Patient Problems Asthma (1726); Fever (1858); Hypersensitivity/Allergic reaction (1907)

Event Date 12/16/2015

Event Type  Injury  

Manufacturer Narrative

Product event summary: the device was returned and analyzed.Analysis was performed and no anomalies were found.This device was included in that field action, but returned product testing found the device did not perform as described in the field action.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.

Event Description

It was reported by the patient that within twelve hours of their implantable cardiac monitor (icm) implant they developed fevers.Since implant the patient stated they have had uncontrollable asthma, pleurisy, and internal hives and have been "very ill for four months." the patient was concerned the fevers were an allergic reaction to the icm.The patient stated their cardiologist decided to remove the icm as a result.Attempts to obtain additional information were unsuccessful.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.

• 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): IPG MFG SWITZERLAND; route du molliau 31; tolochenaz 1131 ; CH 1131
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 5714584
• MDR Text Key: 47082617
• Report Number: 9614453-2016-04265
• 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
• Reporter Occupation: Patient
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/28/2016
• Device Model Number: LNQ11
• Device Catalogue Number: LNQ11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1249-2016
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR