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

Model Number CD1411-36C

Device Problem Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 01/05/2024

Event Type  malfunction  

Manufacturer Narrative

No complaint was received with the return of the device.Failure event observed during analysis.Final analysis found a malfunction of premature battery depletion.Interrogation of the device revealed that device was at end of life (eol) when received.A longevity calculation was performed and found the battery depletion was premature based on the device usage.Electrical testing revealed high current in the hybrid.The cause of the high current was due to a hybrid anomaly.The root cause of the hybrid anomaly could not be conclusively determined.

Event Description

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

• Brand Name: ELLIPSE VR
• 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: 18503902
• MDR Text Key: 332788833
• Report Number: 2017865-2024-00681
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734507707
• UDI-Public: 05414734507707
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/12/2024

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 Expiration Date: 10/31/2015
• Device Model Number: CD1411-36C
• Device Lot Number: 4304142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/05/2024
• Initial Date FDA Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2013
• 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