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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CONFIRM; IMPLANTABLE CARDIAC MONITOR

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ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) CONFIRM; IMPLANTABLE CARDIAC MONITOR Back to Search Results
Model Number DM3500
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Patient Problems Twiddlers Syndrome (2114); No Code Available (3191)
Event Date 07/09/2019
Event Type  Injury  
Manufacturer Narrative
The investigation results will be provided in the final report.
 
Event Description
It was reported that when the patient presented for a follow-up in clinic, the patient had removed their implantable cardiac monitor from the pocket.The patient was stable following and there are no plans to replace the device.
 
Manufacturer Narrative
Analysis was normal.No anomaly was found.
 
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Brand Name
CONFIRM
Type of Device
IMPLANTABLE CARDIAC MONITOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
645 almanor avenue
sunnyvale CA 94085
MDR Report Key8857847
MDR Text Key153213234
Report Number2938836-2019-05980
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,Followup
Report Date 11/19/2020
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 Date07/31/2020
Device Model NumberDM3500
Device Catalogue NumberDM3500
Device Lot NumberS000070081
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/12/2019
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/10/2019
Initial Date FDA Received08/02/2019
Supplement Dates Manufacturer Received08/29/2019
11/19/2020
Supplement Dates FDA Received09/11/2019
11/19/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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