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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 Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Erosion (1750)
Event Date 05/07/2021
Event Type  Injury  
Manufacturer Narrative
Further information was requested but is not yet available.
 
Event Description
It was reported the device was explanted due to erosion.The patient was in stable condition.Further information was requested but is not yet available.
 
Event Description
Additional information received indicated decubito was present but did not result in erosion.The decubito did result in protrusion of the device from the pocket.The physician did not allege a cause.The patient did not experience adverse consequences.
 
Manufacturer Narrative
The device was received and interrogation was normal with a visual screen that was acceptable.Preliminary tests were performed and were normal.No anomalies were observed.
 
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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 Key11892902
MDR Text Key252885798
Report Number2017865-2021-19761
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,Followup
Report Date 07/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date06/01/2022
Device Model NumberDM3500
Device Catalogue NumberDM3500
Device Lot NumberP000113803
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/29/2021
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/11/2021
Initial Date FDA Received05/27/2021
Supplement Dates Manufacturer Received06/14/2021
07/14/2021
Supplement Dates FDA Received06/16/2021
07/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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