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

Model Number CD2411-36Q

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 03/08/2024

Event Type  malfunction  

Event Description

This report is to advise of an event observed during analysis.

Manufacturer Narrative

No complaint was received with the return of the device.Failure event observed during analysis.Final analysis found premature battery depletion caused by high current draw in the hybrid.The device was at elective replacement indicator (eri) when received.A longevity calculation was performed and found the battery depletion was premature based on the device usage.Electrical testing revealed high current drain from the hybrid.The cause of the high input current was found to be a hybrid anomaly.

• Brand Name: ELLIPSE DR
• 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: 18881812
• MDR Text Key: 337447612
• Report Number: 2017865-2024-34600
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734507615
• UDI-Public: 05414734507615
• 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: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/11/2024

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: Other
• Device Expiration Date: 04/30/2018
• Device Model Number: CD2411-36Q
• Device Lot Number: A000020924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2024
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/08/2024
• Initial Date FDA Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2016
• 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