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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 Problem Battery Problem (2885)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/13/2019
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the implantable cardiac monitor (icm) had reached end of service (eos) on day of implant. The icm was replaced. 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.
 
Manufacturer Narrative
Product event summary: the device was returned and analyzed. The returned device identified a failure condition that disappeared during analysis. Hybrid analysis identified a temperature-sensitive battery measurement error but later cleared with no known cause of the fault. The hybrid performed nominally following the clearing of the battery measurement errors. The failing mode could not be reintroduced. 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
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key8669675
MDR Text Key147050106
Report Number9614453-2019-01821
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 Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 12/18/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/14/2019
Device Model NumberLNQ11
Device Catalogue NumberLNQ11
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/28/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/26/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/17/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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