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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. PACEART SYSTEM ELECTROCARDIOGRAPH

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MEDTRONIC, INC. PACEART SYSTEM ELECTROCARDIOGRAPH Back to Search Results
Model Number GC3
Device Problem Data Problem (3196)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/03/2017
Event Type  Malfunction  
Manufacturer Narrative

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

It was reported that when session data from the programmer was imported to the patient management database application as an in-office encounter, the number of atrial high rate episodes did not match. The programmer printout was displaying the number of episodes as (b)(6), but the application listed the number of episodes as (b)(6). The current status of the programmer and application are unknown. No patient complications have been reported as a result of this event.

 
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

It was further reported the customer mis-read the report; values were the same. It was communicated to the customer there were two different values, atrial high rate episodes and auto mode switch episodes. The programmer and application remain in use.

 
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Brand NamePACEART SYSTEM
Type of DeviceELECTROCARDIOGRAPH
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 Key6466824
MDR Text Key72241407
Report Number2182208-2017-00426
Device Sequence Number1
Product Code DPS
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK024278
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/19/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/06/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberGC3
Device Catalogue NumberGC3
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/19/2017
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 04/06/2017 Patient Sequence Number: 1
Treatment
2090 PROGRAMMER
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