MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ELLIPSE DR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD2411-36Q

Device Problem Material Twisted/Bent (2981)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/26/2019

Event Type  malfunction  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.Further information was requested but not received.

Event Description

It was reported that the patient presented for an elective upgrade procedure.During the procedure, it was noted that the header of the patient's implantable cardioverter defibrillator was bent.The device was explanted and replaced.The patient's condition was stable throughout the procedure.

Manufacturer Narrative

The reported event of a 'bent header' was confirmed upon device receipt.Test leads were fully inserted into the header, device set-screws were able to be fully engaged using a lab torque driver and were found to function normally.The test leads remained firmly secured when gently tugged.The device was found acceptable and within manufacturing specs.No anomalies were found.

• Brand Name: ELLIPSE DR
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 9532671
• MDR Text Key: 174927454
• Report Number: 2017865-2019-18670
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734507615
• UDI-Public: 05414734507615
• Combination Product (y/n): N
• PMA/PMN Number: P910023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 05/28/2020

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: 07/31/2018
• Device Model Number: CD2411-36Q
• Device Catalogue Number: CD2411-36Q
• Device Lot Number: A000026002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/26/2019
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: 05/26/2020
• Supplement Dates FDA Received: 05/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 85 YR
• Patient Weight: 62