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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. REVEAL LINQ; DETECTOR AND ALARM, ARRHYTHMIA

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MEDTRONIC, INC. REVEAL LINQ; DETECTOR AND ALARM, ARRHYTHMIA Back to Search Results
Model Number ILR-INSERTION-TOOL
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Tachycardia (2095)
Event Date 10/16/2015
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.Without a lot number or device serial number, the manufacturing date cannot be determined.(b)(4).
 
Event Description
It was reported that during insertion of the implantable cardiac monitor (icm), the patient went into supra ventricular tachycardia (svt).Valsalva maneuvers were used and carotid massage was attempted but failed.The svt broke without the use of medication.The device is still in use.The patient is enrolled in the (b)(6) study.No further 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)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
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 Key5425814
MDR Text Key37842452
Report Number2182208-2016-00558
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 company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 12/10/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberILR-INSERTION-TOOL
Device Catalogue NumberILR-INSERTION-TOOL
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/10/2015
Initial Date FDA Received02/09/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
LNQ11 IMPLANTABLE CARDIAC MONITOR (ICM)
Patient Outcome(s) Required Intervention;
Patient Age00024 YR
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