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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 Inappropriate or Unexpected Reset (2959); No Apparent Adverse Event (3189)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/17/2021
Event Type  malfunction  
Manufacturer Narrative
Further information was requested but not received.
 
Event Description
During a clinic follow-up, the device was found in back-up mode following a mri procedure.Reprogramming of the device is anticipated but no further intervention has been performed.The patient was stable and will continue to be monitored.
 
Manufacturer Narrative
Correction: upon review, the implantable cardiac monitor should not have been submitted as a medical device report (mdr) as the event did not indicate a malfunction caused a serious event.
 
Event Description
Additional information received indicated the backup mode was due to the device reaching normal end of life (eol).
 
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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 Key12391986
MDR Text Key268933901
Report Number2017865-2021-29358
Device Sequence Number1
Product Code MXC
UDI-Device Identifier05414734502573
UDI-Public05414734502573
Combination Product (y/n)N
PMA/PMN Number
K133481
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 09/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/31/2018
Device Model NumberDM2102
Device Catalogue NumberDM2102
Device Lot NumberS000054230
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received09/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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