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

Model Number LNQ11

Device Problem Signal Artifact/Noise (1036)

Patient Problem Itching Sensation (1943)

Event Date 02/04/2016

Event Type  malfunction  

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 noise was captured on the episode log of the implantable cardiac monitor (icm).The patient later reported occasional itching and tenderness at implant site.The icm remains in use.The patient was a participant in the reveal_af study.No 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: 5559916
• MDR Text Key: 42756076
• Report Number: 9614453-2016-02038
• 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: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/14/2016
• Device Model Number: LNQ11
• Device Catalogue Number: LNQ11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2016
• Date Device Manufactured: 02/16/2015
• 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 Age: 00075 YR