MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ELLIPSE DR ICD; Pulse generator, permanent, implantable

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.

• 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 Key: 18323554
• MDR Text Key: 330427855
• Report Number: 2017865-2023-94438
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734507585
• UDI-Public: 05414734507585
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P910023
• Number of Events Reported: 1
• 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 Number: CD2411-36C
• Device Lot Number: A000145458
• 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 Received: 12/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: RIATA; TENDRIL SDX
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Sex: Female