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

Model Number CD1411-36Q

Device Problems Failure to Charge (1085); Energy Output Problem (1431)

Patient Problems Dyspnea (1816); No Consequences Or Impact To Patient (2199); Discomfort (2330)

Event Date 11/16/2020

Event Type  Injury  

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.

Event Description

It was reported that patient presented for implantable cardioverter defibrillator implant.During the procedure, the device issued an alert for possible high voltage circuit damage.It was confirmed that the alert was caused by the electrocautery, and the alert was cleared.The patient was stable.

Event Description

New information states that the patient presented with shortness of breath and chest pain on (b)(6) 2021.The device was explanted and replaced on (b)(6) 2021.

Manufacturer Narrative

The reported field event of failure to charge was confirmed and was due to exposure to electrocautery.Device functionality was tested in the lab and was normal.No anomalies were detected.

• Brand Name: ELLIPSE VR
• 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: 10981140
• MDR Text Key: 220641383
• Report Number: 2017865-2020-21621
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734507738
• UDI-Public: 05414734507738
• 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,Followup
• Report Date: 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: CD1411-36Q
• Device Catalogue Number: CD1411-36Q
• Device Lot Number: A000090939
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/17/2020
• Initial Date FDA Received: 12/10/2020
• Supplement Dates Manufacturer Received: 04/21/2021; 06/24/2021
• Supplement Dates FDA Received: 05/17/2021; 07/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR