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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ELLIPSE DR ICD, US; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ELLIPSE DR ICD, US; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number CD2377-36QC
Device Problem Interrogation Problem (4017)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported that the patient presented in clinic for a follow up.Device interrogation radio frequency telemetry issue on the implantable cardioverter defibrillator (icd).No changes or interventions were performed.The patient was in stable condition.
 
Manufacturer Narrative
Additional information: e1, e2, e3 and e4.
 
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Brand Name
ELLIPSE DR ICD, US
Type of Device
IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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 Key16792408
MDR Text Key313813232
Report Number2017865-2023-18220
Device Sequence Number1
Product Code LWS
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
P910023
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/27/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/21/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/31/2020
Device Model NumberCD2377-36QC
Device Lot NumberS000064316
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/04/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/28/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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