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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 DM2100
Medical Device Problem Codes Failure to Interrogate (1332); Inappropriate or Unexpected Reset (2959)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 09/02/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Implant date is estimated to have occurred in (b)(6) 2017.
 
Event or Problem Description
During a clinic follow-up, the device was observed to be in back-up (bvvi) mode.Additionally, when trying to download the device image, the device was unable to be interrogated.Technical support was contacted, but no intervention has been performed at this time.The patient was stable and will continue to be monitored.
 
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Brand Name
CONFIRM
Common Device Name
IMPLANTABLE CARDIAC MONITOR
Manufacturer (Section D)
ABBOTT
15900 valley view court
sylmar CA 91342
MDR Report Key12487938
Report Number2017865-2021-30691
Device Sequence Number5360688
Product Code MXC
UDI-Device Identifier05414734502597
UDI-Public05414734502597
Combination Product (Y/N)N
Initial Reporter CountryUK
PMA/510(K) Number
K122090
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 09/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date10/31/2018
Device Model NumberDM2100
Device Catalogue NumberDM2100
Device Lot NumberS000041587
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 09/17/2021
Supplement Date Received by Manufacturer09/17/2021
Initial Report FDA Received Date09/17/2021
Supplement Report FDA Received Date09/17/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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