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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 Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/18/2021
Event Type  malfunction  
Event Description
It was reported the asymptomatic patient presented for an explant procedure for an unknown reason.During explant, it was observed the header of the implantable cardiac monitor broke off.The explant continued and was completed without further issue.There was no replacement.There were no patient consequences.
 
Manufacturer Narrative
Analysis was completed.Visual inspection found the device with a broken header which is consistent with explant damage.The device was otherwise normal.
 
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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 Key11288975
MDR Text Key230609273
Report Number2017865-2021-07012
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 03/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/18/2020
Device Model NumberDM3500
Device Catalogue NumberDM3500
Device Lot NumberP000080099
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/29/2021
Was the Report Sent to FDA? No
Date Manufacturer Received03/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age64 YR
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