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U.S. Department of Health and Human Services

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

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MEDTRONIC, INC. REVEAL XT DETECTOR AND ALARM, ARRHYTHMIA Back to Search Results
Model Number 9529
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Stroke/CVA (1770); Unspecified Infection (1930); Pain (1994); Transient Ischemic Attack (2109); Discomfort (2330); Blood Loss (2597)
Event Date 01/01/2016
Event Type  Injury  
Manufacturer Narrative

This information is based entirely on journal literature. This event occurred outside the us. Multiple patients were noted in the article; however, a one to one correlation could not be made with unique device serial numbers. The baseline gender/age of the patients is male/72 years of age. Since no device id was provided, it is unknown if this event has been previously reported. The pma number for this report listed is part of a combination of pmas considered the "1-card" and consists of p820003, p850051, p890003, p930022, p970012 and p980035. Request for additional information will be made and upon receipt a supplemental report will be submitted accordingly. Referenced article: oral anticoagulation after successful atrial fibrillation ablation operations: is it necessary? annals of thoracic surgery. 2016;101(4):1471-1476. 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 cardiac monitors (icms). Multiple patients were noted in the article; however, a one to one correlation could not be made with unique device serial numbers. The article reports that there were complications such as wound infections, "neurological events [stroke or transient ischemic attack], " bleeding complications," and "other device-related complications. " there were reports of patients having their icm removed due to discomfort. " the status of the icms is unknown. No further patient complications have been reported as a result of this event.

 
Manufacturer Narrative

Further analysis of the event prompted a change in the conclusion code.

 
Manufacturer Narrative

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

 
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Brand NameREVEAL XT
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 Key5858596
MDR Text Key51725737
Report Number2182208-2016-01829
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)N
Reporter Country CodeGM
PMA/PMN Number1-CARD
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,L
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/28/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/09/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number9529
Device Catalogue Number9529
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 Received06/28/2016
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

Patient TREATMENT DATA
Date Received: 08/09/2016 Patient Sequence Number: 1
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