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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. REVEAL XT DETECTOR AND ALARM, ARRHYTHMIA

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MEDTRONIC PUERTO RICO OPERATIONS CO. REVEAL XT DETECTOR AND ALARM, ARRHYTHMIA Back to Search Results
Model Number 9529
Device Problems Under-Sensing (1661); Battery Problem (2885)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/08/2017
Event Type  malfunction  
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) experienced intermittent ventricular undersensing on some episodes. It was further reported that the device was end of service (eos). The icm remains in use. No 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 PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
anne schilling
8200 coral sea st ne
mounds view, MN 55112
7635052036
MDR Report Key8183837
MDR Text Key131012493
Report Number3004209178-2018-28055
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
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2015
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 Received12/14/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/04/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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