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

Model Number CD2311-36Q

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 11/03/2023

Event Type  malfunction  

Event Description

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

Manufacturer Narrative

The device was returned as a non-complaint.Interrogation of the device revealed the device was at elective replacement indicator (eri) when received.Longevity was analysis found the battery depletion to be premature.Battery was sent to manufacturer for further analysis and cause of premature battery depletion could not be determined.

• 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: 18197117
• MDR Text Key: 328903539
• Report Number: 2017865-2023-73119
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734505994
• UDI-Public: 05414734505994
• 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: 11/22/2023

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 Expiration Date: 04/30/2014
• Device Model Number: CD2311-36Q
• Device Lot Number: 3853009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/03/2023
• Initial Date FDA Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2012
• 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