PACEART SYSTEM GCIII

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-31 for PACEART SYSTEM GCIII manufactured by Medtronic, Inc..

Event Text Entries

[125772633] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[125772634] 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.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2182208-2018-01986
MDR Report Key8026346
Date Received2018-10-31
Date of Report2018-10-31
Date of Event2018-10-18
Date Mfgr Received2018-10-18
Date Added to Maude2018-10-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactANNE SCHILLING
Manufacturer Street8200 CORAL SEA ST NE
Manufacturer CityMOUNDS VIEW MN 55112
Manufacturer CountryUS
Manufacturer Postal55112
Manufacturer Phone7635052036
Manufacturer G1MEDTRONIC, INC.
Manufacturer Street8200 CORAL SEA STREET NE
Manufacturer CityMOUNDS VIEW MN 55112
Manufacturer CountryUS
Manufacturer Postal Code55112
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NamePACEART SYSTEM
Generic NameELECTROCARDIOGRAPH
Product CodeDPS
Date Received2018-10-31
Model NumberGCIII
Catalog NumberGCIII
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC, INC.
Manufacturer Address8200 CORAL SEA STREET NE MOUNDS VIEW MN 55112 US 55112


Patients

Patient NumberTreatmentOutcomeDate
10 2018-10-31

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.