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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 Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/18/2022
Event Type  malfunction  
Event Description
It was reported that during a remote follow up, an electrogram (egm) of an episode was not received.Abbott technical support was contacted and suspected the egm was prevented due to the scheduled interrogation occurring while the episode was occurring.No intervention has been performed at this time.The patient was in stable condition and will continue to be monitored.
 
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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
richard williamson
15900 valley view court
sylmar, CA 91342
MDR Report Key15920279
MDR Text Key306781152
Report Number2017865-2022-47736
Device Sequence Number1
Product Code MXC
UDI-Device Identifier05415067027320
UDI-Public05415067027320
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K163407
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/08/2023
Device Model NumberDM3500
Device Catalogue NumberDM3500
Device Lot NumberP000145360
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/18/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/12/2022
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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