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: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) 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
 

ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CONFIRM; IMPLANTABLE CARDIAC MONITOR Back to Search Results
Model Number DM3500
Device Problem Under-Sensing (1661)
Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.Further information was requested but not received.
 
Event Description
It was reported there was under-sensing observed on the implantable cardiac monitor.How the issue was discovered and patient symptoms were unknown.Any intervention to address this issue was unknown.The patient's condition was unknown.
 
Event Description
New information received revealed the asymptomatic presented remotely.Upon review of the transmission, it was observed there was undersensing on the implantable cardiac monitor.No programming changes were completed to address this issue.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)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
MDR Report Key10780060
MDR Text Key214404163
Report Number2017865-2020-17059
Device Sequence Number1
Product Code MXC
UDI-Device Identifier05415067027320
UDI-Public05415067027320
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,health
Type of Report Initial,Followup
Report Date 11/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/06/2021
Device Model NumberDM3500
Device Catalogue NumberDM3500
Device Lot NumberS000076156
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age43 YR
-
-