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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO REVEAL DX DETECTOR AND ALARM, ARRHYTHMIA

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MEDTRONIC MED REL MEDTRONIC PUERTO RICO REVEAL DX DETECTOR AND ALARM, ARRHYTHMIA Back to Search Results
Model Number 9528
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erosion (1750); Chest Pain (1776)
Event Date 12/01/2018
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 chest pain near or around the implant site. It was further reported that the icm was corroding and eroding inside the body. The icm remains implanted. No further patient complications have been reported as a result of this event.

 
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Brand NameREVEAL DX
Type of DeviceDETECTOR AND ALARM, ARRHYTHMIA
Manufacturer (Section D)
MEDTRONIC MED REL MEDTRONIC PUERTO RICO
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC MED REL MEDTRONIC PUERTO RICO
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key8754310
MDR Text Key149824864
Report Number3004209178-2019-12804
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK103764
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type OTHER
Reporter Occupation
Type of Report Initial
Report Date 07/02/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/02/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/14/2013
Device MODEL Number9528
Device Catalogue Number9528
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/04/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured06/19/2012
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: 07/02/2019 Patient Sequence Number: 1
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