Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT CONFIRM; IMPLANTABLE CARDIAC MONITOR
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ABBOTT CONFIRM; IMPLANTABLE CARDIAC MONITOR Back to Search Results
Model Number DM3500
Device Problems Under-Sensing (1661); Device Sensing Problem (2917)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/14/2023
Event Type  malfunction  
Event Description
It was reported that r-wave amplitude variation and undersensing resulting in a false pause were observed on the device.No intervention was performed, the device remains implanted and will continue to be monitored.The patient was stable.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key16637089
MDR Text Key312245951
Report Number2017865-2023-16143
Device Sequence Number1
Product Code MXC
UDI-Device Identifier05415067027320
UDI-Public05415067027320
Combination Product (y/n)N
Reporter Country CodeFR
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 Physician
Type of Report Initial
Report Date 03/29/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/11/2023
Device Model NumberDM3500
Device Catalogue NumberDM3500
Device Lot NumberP000139415
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/14/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/14/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-