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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; Pulse generator, permanent, implantable

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ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ELLIPSE DR ICD; Pulse generator, permanent, implantable Back to Search Results
Model Number CD2411-36C
Device Problems Failure to Charge (1085); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problem Discomfort (2330)
Event Date 11/22/2023
Event Type  Injury  
Event Description
It was reported the patient presented for surgery.During the procedure, the implantable cardioverter defibrillator delivered inappropriate shocks due to electrocautery exposure.The inappropriate shocks caused the patient to start coming out of anesthesia.The implantable cardioverter defibrillator alerted for shorted output stage detection.No changes or intervention was performed.The patient condition was unknown.
 
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Brand Name
ELLIPSE DR ICD
Type of Device
Pulse generator, permanent, implantable
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 Key18323554
MDR Text Key330427855
Report Number2017865-2023-94438
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
Reporter Occupation Nurse
Type of Report Initial
Report Date 12/13/2023
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 Model NumberCD2411-36C
Device Lot NumberA000145458
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/24/2023
Initial Date FDA Received12/13/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/07/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
RIATA; TENDRIL SDX
Patient Outcome(s) Other;
Patient Age64 YR
Patient SexFemale
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