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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IPG MFG SWITZERLAND REVEAL LINQ; DETECTOR AND ALARM, ARRHYTHMIA
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IPG MFG SWITZERLAND REVEAL LINQ; DETECTOR AND ALARM, ARRHYTHMIA Back to Search Results
Model Number LNQ11
Device Problems Over-Sensing (1438); Under-Sensing (1661)
Patient Problem Erosion (1750)
Event Date 10/25/2016
Event Type  malfunction  
Event Description
It was reported that the implantable cardiac monitor (icm) showed evidence of false pause episodes due to undersensing.Oversensing was noted as well.Later the patient was seen at the hospital and the device was protruding out of their skin.The device was removed.No patient complications have been reported as a result of this event.
 
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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 Key6164624
MDR Text Key62319414
Report Number9614453-2016-07625
Device Sequence Number1
Product Code DSI
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K132649
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 10/25/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date07/14/2017
Device Model NumberLNQ11
Device Catalogue NumberLNQ11
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/25/2016
Initial Date FDA Received12/09/2016
Date Device Manufactured07/22/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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