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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 DM2102
Device Problems Failure to Interrogate (1332); Reset Problem (3019)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/04/2019
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 prior to the implant procedure, the implantable cardiac monitor was unable to interrogate with the programmer but the device was implanted.After leaving the procedure room, when entering the information of the patient, an alert appeared indicating that the device was in safety mode.Reactivating the device was attempted but unsuccessful.The device was then explanted and replaced.There was no patient consequences before, during and after the procedure.
 
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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
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
645 almanor avenue
sunnyvale CA 94085
Manufacturer Contact
elizabeth boltz
15900 valley view court
sylmar, CA 91342
MDR Report Key9502092
MDR Text Key172382372
Report Number2938836-2019-17064
Device Sequence Number1
Product Code MXC
UDI-Device Identifier05414734502573
UDI-Public05414734502573
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K133481
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 01/10/2020
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? Yes
Device Operator Health Professional
Device Expiration Date04/30/2020
Device Model NumberDM2102
Device Catalogue NumberDM2102
Device Lot NumberS000069396
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/04/2019
Initial Date FDA Received12/20/2019
Supplement Dates Manufacturer Received01/10/2020
Supplement Dates FDA Received01/10/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/01/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age49 YR
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