MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ELLIPSE DR ICD; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number CD2411-36C

Device Problems Pacing Problem (1439); Under-Sensing (1661)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/12/2024

Event Type  Injury  

Event Description

It was reported that the patient's implantable cardioverter defibrillator exhibited under-sensing causing inappropriate mode switch.Programming changes were performed.There were no patient consequences.

Event Description

Additional information received noted that the device was explanted and replaced on (b)(6) 2024.The patient was in stable condition.

Manufacturer Narrative

The reported event of under-sensing was confirmed while the reported event of inappropriate mode switch was not confirmed.As received, a device returned for analysis.Review of device records revealed that the cause of under-sensing was due to external (non-device related) factors.The device behaved as expected and according to its programmed settings.No other anomalies were identified.

• 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: 19009631
• MDR Text Key: 339013786
• Report Number: 2017865-2024-37280
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734507585
• UDI-Public: (01)05414734507585(10)4913307(17)161130
• 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,Followup,Followup
• Report Date: 05/26/2024

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2016
• Device Model Number: CD2411-36C
• Device Lot Number: 4913307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/12/2024
• Initial Date FDA Received: 04/01/2024
• Supplement Dates Manufacturer Received: 04/22/2024; 05/10/2024
• Supplement Dates FDA Received: 05/01/2024; 05/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2014
• 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: OPTISENSE LEAD; RIATA LEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female