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

Model Number 9529

Device Problems Over-Sensing (1438); Unable to Obtain Readings (1516)

Patient Problem Atrial Fibrillation (1729)

Event Date 05/21/2012

Event Type  Injury  

Event Description

A journal article was reviewed which contained information regarding this implantable loop recorder (ilr).The article discusses programming detection settings for different patient populations.Multiple patients were noted in the article; however, a one to one correlation could not be made with unique ilr/serial numbers.Multiple failure modes were referenced in the article, with no specific ilr model indications.The failure modes were noted as: noise, and "false positive atrial fibrillation (af) detection." the article proposes recommendations for programming the ilr.The status of the ilr is unknown.Additional information from follow up with the author indicated that the "noise" is "primarily because of myopotentials due to strenuous muscular activity performed by the patient." the ilr itself did not generate the noise.The explanation of "false positives" indicated are fully disclosed the clinical manual and not due to a defective device; however, all false positives cannot be explained.Per the author, "the reveal device does not provide automatic therapy in just provides information, and physicians can easily determine if an episode is false from the stored electrogram." there were no patient complications reported as a result of this event.

Manufacturer Narrative

This information is based entirely on journal literature.All information provided is included in this report.Correspondence was sent to the author requesting additional information, and has been added to this report.If additional relevant information is received, a supplemental report will be submitted.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.Referenced article: programming reveal xt af detection settings for different patient populations.¿ taken from ieee trans biomed eng.2008.March.55 (3): 1219-24.(b)(4).

• 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 CARDIAC RHYTHM DISEASE MGMT; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: nashoane fulwood-kelley ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635260583
• MDR Report Key: 3745298
• MDR Text Key: 4220473
• Report Number: 2182208-2014-01059
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103764
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/21/2014

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?: No
• Initial Date Manufacturer Received: 02/21/2014
• Initial Date FDA Received: 04/11/2014
• 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