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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. REVEAL DX DETECTOR AND ALARM, ARRHYTHMIA

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MEDTRONIC, INC. 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 Problem Hemorrhage/Bleeding (1888)
Event Date 01/01/2021
Event Type  Injury  
Manufacturer Narrative

This information is based entirely on journal literature. Medtronic was made aware of this event through a search of literature publications. This event occurred outside the us. Patient information is limited due to confidentiality concerns. The event only occurred with one patient but specific details on the patient were not provided. 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. A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly. Referenced article: diagnostic value of implantable loop recorders in patients with unexplained syncope or palpitations. Annals of noninvasive electrocardiology. 2021;00:e12864. Doi: 10. 1111/anec. 12864. If information is provided in the future, a supplemental report will be issued.

 
Event Description

A journal article was reviewed that contained information regarding implantable cardiac monitors (icm). The article reports one patient who experienced bleeding post implant of their icm. A hemostasis revision was performed. The status/disposition of the device is unknown. 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, 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 Key12035540
MDR Text Key257377146
Report Number2182208-2021-02515
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)N
PMA/PMN NumberK103764
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,L
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 06/21/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/21/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number9528
Device Catalogue Number9528
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 Received06/09/2021
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: 06/21/2021 Patient Sequence Number: 1
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