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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CONFIRM; IMPLANTABLE CARDIAC MONITOR
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CONFIRM; IMPLANTABLE CARDIAC MONITOR Back to Search Results
Model Number DM3500
Device Problems Premature Discharge of Battery (1057); No Apparent Adverse Event (3189)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/29/2021
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.
 
Event Description
It was reported one-day post-implant, low battery voltage was observed.The device remains implanted.There were no adverse health consequences to the patient.
 
Manufacturer Narrative
Correction: please retract this report 2017865-2021-08833, as the event did not indicate a malfunction caused a serious event.
 
Event Description
New information received indicated that the device had a normal expected behavior and no anomaly.
 
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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 Key11334293
MDR Text Key232069455
Report Number2017865-2021-08833
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,foreig
Type of Report Initial,Followup
Report Date 03/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/27/2022
Device Model NumberDM3500
Device Catalogue NumberDM3500
Device Lot NumberP000106967
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received02/18/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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