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

Model Number 9529

Device Problems Unable to Obtain Readings (1516); Device Sensing Problem (2917)

Patient Problems Unspecified Infection (1930); Discomfort (2330)

Event Date 12/03/2018

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 and as multiple patients were noted a one to one correlation cannot be made.A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article: telemonitoring with an implantable loop recorder in outpatient heart failure care.One year follow up report from a prospective observational dutch multicenter study.Netherland heart journal, doi.Org/10.1007/s12471-018-1198-x.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).Information in the article revealed that two ilrs were removed from the patients due to local discomfort, one patient developed a superficial wound infection, and for one patient the data was lost.Additionally, in twenty patients atrial fibrillation (af) was detected by the ilr and twelve were determined to be false-positive.Following, when the duration for detection was increased af was detected by the ilr in thirteen patient¿s and six were found to be false-positive.The status of the devices is not known.Further follow up did not yet yield any additional information.No further patient complications have been reported as a result of this event.

• 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: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 8213097
• MDR Text Key: 131942473
• Report Number: 2182208-2019-00017
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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
• Report Date: 01/03/2019

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: 9529
• Device Catalogue Number: 9529
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2018
• Initial Date FDA Received: 01/03/2019
• 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): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 78