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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 Bacterial Infection (1735); Purulent Discharge (1812); Fever (1858); Hyperemia (1904); Pain (1994); Skin Inflammation (2443)
Event Date 01/03/2019
Event Type  Injury  
Manufacturer Narrative

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

 
Event Description

It was reported that the implantable cardiac monitor (icm) patient experienced infection. It was reported that the skin around the icm was inflamed, and the patient experienced pain, hyperaemia, fever and pus. The patient was treated with antibiotics. The icm was explanted. The patient is a participant in the (b)(6) study. No further patient complications have been reported as a result of this event.

 
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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
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key8905826
MDR Text Key154722729
Report Number2182208-2019-01511
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)N
Reporter Country CodeHU
PMA/PMN NumberK103764
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 08/19/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/19/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
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 Received08/01/2019
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: 08/19/2019 Patient Sequence Number: 1
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