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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO REVEAL XT; DETECTOR AND ALARM, ARRHYTHMIA
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MEDTRONIC MED REL MEDTRONIC PUERTO RICO 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 Problem Discomfort (2330)
Event Date 12/04/2014
Event Type  Injury  
Event Description
It was reported that the implantable cardiac monitor (icm) was causing the patient discomfort.The icm was removed and a new icm was implanted.No further patient complications have been reported as a result of this event.
 
Manufacturer Narrative
The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.(b)(4).
 
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Brand Name
REVEAL XT
Type of Device
DETECTOR AND ALARM, ARRHYTHMIA
Manufacturer (Section D)
MEDTRONIC MED REL MEDTRONIC PUERTO RICO
ceiba norte industrial park, r
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC CARDIAC RHYTHM HEART FAILURE
8200 coral sea st ne
mounds view MN 55112
Manufacturer Contact
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key4499479
MDR Text Key5442311
Report Number3004209178-2015-02442
Device Sequence Number1
Product Code DSI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K103764
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 12/04/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/10/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date09/14/2013
Device Model Number9529
Device Catalogue Number9529
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/04/2014
Date Device Manufactured09/14/2012
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age00052 YR
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