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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 Problem Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/06/2021
Event Type  Injury  
Event Description
It was reported that the physician elected to explant the implantable cardiac monitor for unknown reason.There were no patient consequences.
 
Manufacturer Narrative
The reported field event of explanted for unknown reasons was not confirmed in the laboratory.The device was tested on the bench and using automated testing equipment, and no anomalies were found.Further information was requested but not received.Correction d6b explant date should have been included in the initial report.
 
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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 Key12414529
MDR Text Key269552700
Report Number2017865-2021-29554
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 health professional,user faci
Type of Report Initial,Followup
Report Date 10/06/2021
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 Date01/30/2022
Device Model NumberDM3500
Device Catalogue NumberDM3500
Device Lot NumberP000107178
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/13/2021
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 08/13/2021
Initial Date FDA Received09/02/2021
Supplement Dates Manufacturer Received09/15/2021
Supplement Dates FDA Received10/06/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age59 YR
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