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

Model Number CD2411-36C

Device Problem Inappropriate or Unexpected Reset (2959)

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

Event Date 04/12/2024

Event Type  Injury  

Event Description

It was reported that the patient's implantable cardioverter defibrillator (icd) had inappropriately undergone hardware reset.It was noted that back-up defibrillation was disabled due to reset.The icd was explanted and replaced.The patient was stable.

Manufacturer Narrative

The reported field event of backup operation was confirmed in the lab.Final analysis revealed the device had a power-on reset (por) during high voltage therapy delivery.Information from the field indicated that the patient had external defibrillation during an ablation procedure, and the device was found in backup operation afterwards.The cause of the reported event was due to the external defibrillation.After the device was restored from backup mode, functional testing was performed.No anomalies were detected.

• 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: 19215656
• MDR Text Key: 341417740
• Report Number: 2017865-2024-40098
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734507585
• UDI-Public: (01)05414734507585(10)A000018554(17)180228
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/29/2024

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: 02/28/2018
• Device Model Number: CD2411-36C
• Device Lot Number: A000018554
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/12/2024
• Initial Date FDA Received: 04/30/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2016
• 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: DURATA; SJM ATRIAL LEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female