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

Model Number LNQ11

Device Problems Over-Sensing (1438); Under-Sensing (1661); Invalid Sensing (2293)

Patient Problems Unspecified Infection (1930); Skin Erosion (2075); Discomfort (2330)

Event Date 02/26/2013

Event Type  Injury  

Manufacturer Narrative

This information is based entirely on journal literature.All information provided is included in this report.Multiple patients were noted in the article; however, a one to one correlation could not be made with unique product serial numbers.Patient information is limited due to confidentiality concerns.The gender of the baseline characteristics is male and the baseline age is (b)(6) years old.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.Request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article: ¿assessing arrhythmia burden after catheter ablation of atrial fibrillation using an implantable loop recorder: the abacus study.¿ journal of cardiovascular electrophysiology 2013;24:875-881.Doi: 10.1111/jce.12141.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 that contained information regarding implantable loop recorders (ilr).Multiple patients were noted in the article; however, a one to one correlation could not be made with unique serial numbers with the available information provided.The author reported that there were patients who had false device detections; with the following ¿causes,¿ per the author: noise, t-wave oversensing (twos), and loss of electrode contact and/or poor electrode contact.The device also ¿falsely¿ detected/¿misclassified¿ asystole and ventricular tachycardia (vt) due to under/oversensing.There was also one patient who had skin erosion, and one patient who had pocket infection which required the device to be explanted.One patient requested the removal of the ilr due to ¿local discomfort.¿ one patient requested removal for ¿cosmetic reasons.¿ the status/location of the ilr is unknown.Further follow up did not yet yield any additional information.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

All information provided is included in this report.No further information is available.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was obtained through follow up with the author who indicated that there was no further information available.

• 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, 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 Key: 6936403
• MDR Text Key: 89085209
• Report Number: 2182208-2017-01792
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/07/2017

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: LNQ11
• Device Catalogue Number: LNQ11
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/07/2017
• Initial Date FDA Received: 10/10/2017
• Supplement Dates Manufacturer Received: 10/19/2017
• Supplement Dates FDA Received: 12/07/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 59 YR