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

Model Number 9529

Device Problems Over-Sensing (1438); Under-Sensing (1661); Device Sensing Problem (2917)

Patient Problems Arrhythmia (1721); No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/2010

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.Of note, multiple patients were noted in the article; however, a one to one correlation could not be made with unique serial numbers.The model listed in the report is a representative of the model family, as there is no specific model listed.The baseline gender/age of the patients represented in the article is male/57 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: performance of a new leadless implantable cardiac monitor in detecting and quantifying atrial fibrillation results of the xpect trial.Circulation: arrhythmia and electrophysiology.2010; 3 (2):141-147.Doi://10.1161/circep.109.877852 of note, the clinical trial is clinical trial registration¿clinicaltrials.Gov identifier nct00680927.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was reviewed which contained information regarding implantable loop recorders (ilrs).The article reported that there were ¿false positive¿ detections¿ noted.The misdetections were alleged to be due to myopotentials, oversensing, and r-wave undersensing.There were also premature ventricular or atrial complexes (pvcs or pacs) and other arrhythmias noted in patients.The status 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

If information is provided in the future, a supplemental report will be issued.

• Brand Name: REVEAL XT
• 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 8809518
• MDR Text Key: 151692308
• Report Number: 2182208-2019-01315
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K103764
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9529
• Device Catalogue Number: 9529
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2019
• 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): Other
• Patient Age: 57 YR