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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT CONFIRM; IMPLANTABLE CARDIAC MONITOR
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ABBOTT CONFIRM; IMPLANTABLE CARDIAC MONITOR Back to Search Results
Model Number DM2102
Device Problems Failure to Interrogate (1332); Data Problem (3196)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/19/2022
Event Type  malfunction  
Event Description
During follow-up, an error message and failure to interrogate was observed on the device.Abbott technical support was contacted and confirmed the event.No intervention has been performed at this time.The patient was in stable condition and will continue to be monitored.
 
Event Description
Additional information received indicated the event was resolved by performing a firmware download.The patient was in stable condition.
 
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Brand Name
CONFIRM
Type of Device
IMPLANTABLE CARDIAC MONITOR
Manufacturer (Section D)
ABBOTT
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ABBOTT
15900 valley view court
sylmar CA 91342
Manufacturer Contact
sonali arangil
15900 valley view court
sylmar, CA 91342
MDR Report Key14599606
MDR Text Key293334007
Report Number2017865-2022-11769
Device Sequence Number1
Product Code MXC
UDI-Device Identifier05414734502573
UDI-Public05414734502573
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K133481
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 06/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/05/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2019
Device Model NumberDM2102
Device Catalogue NumberDM2102
Device Lot NumberS000066851
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/10/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/29/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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