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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 LNQ11
Device Problem Migration or Expulsion of Device (1395)
Patient Problem Pocket Erosion (2013)
Event Date 01/01/2016
Event Type  Injury  
Manufacturer Narrative

This information is based entirely on journal literature. This event occurred outside the us. All information provided is included in this report. Patient information is limited due to confidentiality concerns. Without a lot number or device serial number, the manufacturing date cannot be determined. Since no device id was provided, it is unknown if this event has been previously reported. A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly. Referenced article: ¿ejectable loop recorders? heart rhythm society. 2016. Http://dx. Doi. Org/10. 1016/j. Hrthm. 2016. 05. 027. Concomitant medical products: remote home monitor. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.

 
Event Description

A journal article was reviewed regarding this patient¿s implantable loop recorder (ilr). According to the article, fourteen weeks after implantation of the ilr, the patient activator no longer communicated and the remote monitor ¿abruptly stopped transmitting scheduled daily reports. ¿ of note, four weeks prior, the patient underwent an ablation procedure. The patient indicated that there were no signs of infection or erosion, and denied any trauma to the device. The patient did mention that there was a small amount of blood at the insertion site two weeks after implantation, but only on one day. The incision site was ¿well healed. ¿ the ilr could not be felt. A programmer was used to locate the device without success. The patient underwent a chest radio-graph which confirmed that the device was no longer at the implant site. Additional scans were done to ensure that the device had not migrated elsewhere. The status of the device is unknown. Additional information was obtained through follow up with the author who indicated that there were "no allegations or product specific complications. " the author also indicated that there were no additional surgical/medical interventions taken and the patient is doing "well" and has not had any further issues related to this event. 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.

 
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Brand NameREVEAL LINQ
Type of DeviceDETECTOR AND ALARM, ARRHYTHMIA
Manufacturer (Section D)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer (Section G)
MEDTRONIC, INC.
8200 coral sea street ne
mounds view MN 55112
Manufacturer Contact
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key6005154
MDR Text Key56757741
Report Number2182208-2016-02253
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberK132649
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,L
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 07/09/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/06/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberLNQ11
Device Catalogue NumberLNQ11
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/09/2016
Was Device Evaluated By Manufacturer? No Answer Provided
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: 10/06/2016 Patient Sequence Number: 1
Treatment
PATIENT ACTIVATOR
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