CONFIRM DM3500

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-23 for CONFIRM DM3500 manufactured by St. Jude Medical, Inc.(crm-sylmar).

Event Text Entries

[184469769] The results of the investigation are inconclusive since the device was not returned for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined.
Patient Sequence No: 1, Text Type: N, H10


[184469770] It was reported that the patient presented remotely. Review of the transmissions from their implantable cardiac monitor (icm) showed false pause episodes due to intermittent ventricular undersensing. Programming changes were discussed but were not made. There were no patient symptoms reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2017865-2020-04009
MDR Report Key9865232
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2020-03-23
Date of Report2020-03-23
Date of Event2020-03-09
Date Mfgr Received2020-03-12
Device Manufacturer Date2018-08-30
Date Added to Maude2020-03-23
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 ContactELIZABETH BOLTZ
Manufacturer Street15900 VALLEY VIEW COURT
Manufacturer CitySYLMAR CA 91342
Manufacturer CountryUS
Manufacturer Postal91342
Manufacturer G1ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
Manufacturer Street15900 VALLEY VIEW COURT
Manufacturer CitySYLMAR CA 91342
Manufacturer CountryUS
Manufacturer Postal Code91342
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCONFIRM
Generic NameIMPLANTABLE CARDIAC MONITOR
Product CodeMXC
Date Received2020-03-23
Model NumberDM3500
Catalog NumberDM3500
Lot NumberP000067247
Device Expiration Date2020-02-20
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerST. JUDE MEDICAL, INC.(CRM-SYLMAR)
Manufacturer Address15900 VALLEY VIEW COURT SYLMAR CA 91342 US 91342


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-23

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