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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 GCIII
Device Problem Data Problem (3196)
Patient Problem No Patient Involvement (2645)
Event Date 10/18/2018
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 caller stated that when the device was interrogated the device was elective replacement indicator (eri) with settings of vvi 65. After uploading the programmer data to the patient management database application, the atrial ohms were displayed as 67 ohms. The atrial lead was off due to the device being at eri and possibly due to an erroneous number during the data transfer. The caller was advised to test the lead during a generator change to ensure the atrial lead was functioning normally. The application remains in use. There was no patient involvement.

 
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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 Key8026346
MDR Text Key125772633
Report Number2182208-2018-01986
Device Sequence Number1
Product Code DPS
Combination Product (Y/N)N
Reporter Country CodeUS
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 10/31/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/31/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberGCIII
Device Catalogue NumberGCIII
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 Received10/18/2018
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

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