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

Model Number CD2411-36C

Device Problems Over-Sensing (1438); Use of Device Problem (1670)

Patient Problem Arrhythmia (1721)

Event Date 02/16/2024

Event Type  malfunction  

Event Description

Related manufacturer report number: 2017865-2024-34267.It was reported that the patient was completely pacemaker dependent.The patient presented for a generator change.The patient had existing non-abbot right atrial (ra) and right ventricular (rv) leads.A new abbott implantable cardioverter defibrillator (icd) and ra lead was to be implanted and the non-abbott ra lead was to be replaced leaving the non-abbott rv lead.It was noted during the procedure that no escape rhythm was observed.All testing through a pacing system analyzer (psa) on the new abbott right atrial (ra) lead appeared normal.When the new ra lead was connected to the new implantable cardioverter defibrillator (icd), any time an atrial pace would occur, cross talk appeared and inappropriately inhibited ventricular pacing.The physician tried a new location and lead, but crosstalk was still observed.Cross talk continued to occur.No back up device was available, so a biventricular device with a plugged left ventricular port was used.Crosstalk still appeared; however, this was appropriately covered by ventricular blanking.No cross talk was visible on the new ra and right ventricular (rv) lead in dual chamber pacing mode through the analyzer.The patient was stable following the procedure.

Manufacturer Narrative

The reported field event of crosstalk could not be confirmed in the lab.Telemetry, impedance, sensing, pacing, and high voltage (hv) output functions of the device were tested and found to be normal.

• 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: 18848384
• MDR Text Key: 337071825
• Report Number: 2017865-2024-34266
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CD2411-36C
• Device Lot Number: A000148235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/16/2024
• Initial Date FDA Received: 03/06/2024
• Supplement Dates Manufacturer Received: 03/27/2024
• Supplement Dates FDA Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2023
• 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: KENTROX - SL-S RV LEAD
• Patient Age: 90 YR
• Patient Sex: Female