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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 Migration or Expulsion of Device (1395)
Patient Problems Erosion (1750); Dyspnea (1816); Shock (2072); Impaired Healing (2378)
Event Date 02/01/2017
Event Type  Injury  
Manufacturer Narrative

This information is based entirely on journal literature. Multiple patients and multiple manufacturers were noted in the article; however, a one to one correlation could not be made with unique device/serial numbers. The gender of the baseline characteristics is male and the baseline age is 71 years old. Without a lot number or device serial number, the manufacturing date cannot be determined. Since no device id was provided, it is unknown if this event has been previously reported. Request for additional information will be made and upon receipt a supplemental report will be submitted accordingly. Referenced article:baseline demographics, safety, and patient acceptance of an insertable cardiac monitor for atrial fibrillation screening: the reveal-af study. Journal of atrial fibrillation. 2017; 9(5). 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 which contained information regarding implantable cardiac monitors. 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 adverse events including device migration/ site erosion, impaired healing, shock/dyspnea, insertion site pain, and oversensing requiring repositioning of the device. The status of the device is unknown. Further follow up did not yet yield any additional information. 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, 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 Key6779998
MDR Text Key82333433
Report Number2182208-2017-01105
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberK103764
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,L
Reporter Occupation
Type of Report Initial
Report Date 06/26/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/09/2017
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 Received06/26/2017
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: 08/09/2017 Patient Sequence Number: 1
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