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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL REVEAL LINQ DETECTOR AND ALARM, ARRHYTHMIA

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MEDTRONIC EUROPE SARL REVEAL LINQ DETECTOR AND ALARM, ARRHYTHMIA Back to Search Results
Model Number LNQ11
Device Problems Battery Problem (2885); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Discomfort (2330)
Event Date 03/16/2016
Event Type  Injury  
Manufacturer Narrative
This device was reported as included in the field action. Based on the information received and without the return of the product, it cannot be confirmed that this device performed as described in the field action. It is included in the field action in the abundance of caution. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the implantable cardiac monitor (icm) patient initially had pain associated with the icm and claimed that the device hurt. The icm was repositioned and remained in use. It has been further reported that the icm has been explanted due to end of life (eol). No further patient complications have been reported as a result of this event.
 
Manufacturer Narrative
This device was reported as included in the field action noted but returned product investigation found the device did not perform as described in the field action. The device is no longer included as part of the field action. Product event summary: the device was returned and analyzed. Analysis of the device revealed normal battery depletion. The battery indicator signifying that it is time for device replacement occurred after explant. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameREVEAL LINQ
Type of DeviceDETECTOR AND ALARM, ARRHYTHMIA
Manufacturer (Section D)
MEDTRONIC EUROPE SARL
route du molliau 31
case postale
tolochenaz vaud 1131
CH 1131
Manufacturer (Section G)
MEDTRONIC EUROPE SARL
route du molliau 31
case postale
tolochenaz vaud 1131
CH 1131
Manufacturer Contact
lisa robertson
8200 coral sea st ne
mounds view, MN 55112
7635262723
MDR Report Key8270405
MDR Text Key133847518
Report Number9614453-2019-00235
Device Sequence Number1
Product Code DSI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K132649
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 03/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/28/2016
Device Model NumberLNQ11
Device Catalogue NumberLNQ11
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/09/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/20/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/29/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-1249-2016

Patient Treatment Data
Date Received: 01/23/2019 Patient Sequence Number: 1
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