PACEART OPTIMA POS12D15

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-07 for PACEART OPTIMA POS12D15 manufactured by Medtronic, Inc..

Event Text Entries

[42790812] The information submitted reflects all relevant data received. If additional relevant information is received, a supplemental report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


[42790813] It was reported that the patient management database application was showing right ventricular (rv) lead values on a single chamber device with a single lead implanted in the atrium. The caller was advised this may be a data mapping issue and has been escalated to the development team. No patient complications have been reported as a result of this event. On (b)(6) 2016, 07:03:01: it was later reported that the device manufacturer was contacted to fix how they are creating the file. Until the issue is resolved the data in the patient management database application will need to be manually fixed.
Patient Sequence No: 1, Text Type: D, B5


[62588887] 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.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2182208-2016-01000
MDR Report Key5559417
Date Received2016-04-07
Date of Report2016-10-19
Date of Event2016-02-26
Date Mfgr Received2016-10-19
Date Added to Maude2016-04-07
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
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 Report3

Device Details

Brand NamePACEART OPTIMA
Generic NameANALYZER, PACEMAKER GENERATOR FUNCTION, INDIRECT
Product CodeKRE
Date Received2016-04-07
Model NumberPOS12D15
Catalog NumberPOS12D15
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
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 2016-04-07

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