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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) JOT DX¿ ICM; Recorder, event, implantable cardiac, (without arrhythmia detection)

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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) JOT DX¿ ICM; Recorder, event, implantable cardiac, (without arrhythmia detection) Back to Search Results
Model Number DM4500
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930)
Event Type  Injury  
Manufacturer Narrative
A device history record (dhr) review was performed, and all required manufacturing processes and inspection steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.Review of the sterilization records confirmed normal sterilization cycles for the products.The product was returned, and visual inspection was normal.The cause of infection could not be traced to the device.
 
Event Description
It was reported that patient presented to emergency department with a bleeding and purulent discharge.It was noted that patient had an infection.Implantable cardiac monitor (icm) was explanted.Patient condition was unknown.
 
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Brand Name
JOT DX¿ ICM
Type of Device
Recorder, event, implantable cardiac, (without arrhythmia detection)
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.(CRM-SYLMAR)
15900 valley view court
sylmar CA 91342
Manufacturer Contact
richard williamson
15900 valley view court
sylmar, CA 91342
MDR Report Key19043191
MDR Text Key339393340
Report Number2017865-2024-36959
Device Sequence Number1
Product Code MXC
UDI-Device Identifier05415067040046
UDI-Public(01)05415067040046(10)P000189664(17)250620
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K163407
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Physician
Type of Report Initial
Report Date 04/04/2024
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 Model NumberDM4500
Device Lot NumberP000189664
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/18/2024
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/18/2024
Initial Date FDA Received04/04/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/23/2023
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) Other; Required Intervention;
Patient Age87 YR
Patient Weight62 KG
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