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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 Nonstandard Device (1420); Manufacturing, Packaging or Shipping Problem (2975); Appropriate Term/Code Not Available (3191)
Patient Problems Syncope (1610); Death (1802); Pain (1994); Seizures (2063); Skull Fracture (2077); Injury (2348)
Event Date 07/17/2016
Event Type  Death  
Manufacturer Narrative

Non-healthcare professional 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 sustained "serious, painful and permanent injuries" which caused the patient "to endure great pain and suffering" due to the icm being "negligently, carelessly, and recklessly designed, manufactured, imported, distributed and sold". It was further reported that the device "deviated from the design specifications, failed to properly affix warnings or instructions and (was) defectively designed and manufactured". The device is no longer in use. No further 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

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's physician did not receive data showing a four second variance in patient's heartbeat until four days after the data was recorded. It was alleged by an attorney that during the four day time frame the patient experienced a second variance in their heartbeat which caused the icm patient to lose consciousness, fall and suffer serious bodily injuries including a fractured skull which allegedly caused a massive seizure which led to the patient's death.

 
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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 Key7738740
MDR Text Key115673424
Report Number9614453-2018-02707
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK132649
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 06/12/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/01/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/14/2017
Device MODEL NumberLNQ11
Device Catalogue NumberLNQ11
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/24/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured03/21/2016
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: 08/01/2018 Patient Sequence Number: 1
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