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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 Migration or Expulsion of Device (1395); Migration (4003)
Patient Problems No Consequences Or Impact To Patient (2199); Discomfort (2330)
Event Date 12/07/2020
Event Type  Injury  
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 that the patient presented in clinic with complaints of discomfort and device movement.It was revealed that the implantable cardiac monitor had migrated.The device was explanted.The patient was stable.
 
Manufacturer Narrative
The reported field event of migration was not confirmed.The device was tested on the bench and no anomalies were found.
 
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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 Key11069240
MDR Text Key223577284
Report Number2017865-2020-23536
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 03/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date01/27/2022
Device Model NumberDM3500
Device Catalogue NumberDM3500
Device Lot NumberP000106920
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/09/2021
Was the Report Sent to FDA? No
Date Manufacturer Received03/16/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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