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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; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ELLIPSE DR ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR Back to Search Results
Model Number CD2411-36C
Device Problems Incorrect Interpretation of Signal (1543); Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/09/2022
Event Type  Injury  
Event Description
It was reported that the patient presented in clinic for a follow up due to receiving shocks.Clinician interrogation revealed inappropriate shocks due to incorrect interpretation of a super ventricular tachycardia on the implantable cardioverter defibrillator.Programming changes were performed to resolve the issue.The patient was in stable condition.
 
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Brand Name
ELLIPSE DR ICD
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
sonali arangil
15900 valley view court
sylmar, CA 91342
MDR Report Key15499321
MDR Text Key300724765
Report Number2017865-2022-39620
Device Sequence Number1
Product Code NVZ
UDI-Device Identifier05414734507585
UDI-Public05414734507585
Combination Product (y/n)N
Reporter Country CodeUS
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
Report Date 09/27/2022
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 Date07/31/2022
Device Model NumberCD2411-36C
Device Catalogue NumberCD2411-36C
Device Lot NumberA000099341
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/09/2022
Initial Date FDA Received09/28/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/28/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
1888TC/52 ATRIAL; 2088TC/58 RIGHT VENTRICLE
Patient Outcome(s) Other;
Patient Age73 YR
Patient SexMale
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