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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 DM3500
Device Problems Failure to Capture (1081); Under-Sensing (1661)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
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.
 
Event Description
During follow-up, there was some false pause episodes due to the device undersensing and loss of capture noted on the device.No intervention was performed to resolve the event and the patient was in stable condition.
 
Event Description
During follow-up, there was some false pause episodes due to the device undersensing and loss of tissue contact.No intervention was performed as the event resolved after a few days, the healthcare professional believes the issue was related to pocked size during implant.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
MDR Report Key9632912
MDR Text Key176439543
Report Number2017865-2020-01001
Device Sequence Number1
Product Code MXC
Combination Product (y/n)N
PMA/PMN Number
K163407
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 02/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberDM3500
Device Catalogue NumberDM3500
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received02/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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