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

Model Number CD1411-36Q

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Pocket Erosion (2013); Twiddlers Syndrome (2114)

Event Date 08/11/2020

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

Related manufacturer reference number: 2017865-2020-12311.It was reported the patient presented for a lead extraction procedure due to twiddlers syndrone.Prior to procedure, it was noted that the patient had an infection and the implantable cardioverter defibrillator had eroded out of the pocket.The physician explanted and replaced the device and right ventricular lead.The patient was stable.

• 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
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 10475250
• MDR Text Key: 205068997
• Report Number: 2017865-2020-12310
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734507738
• UDI-Public: 05414734507738
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/31/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: CD1411-36Q
• Device Catalogue Number: CD1411-36Q
• Device Lot Number: A000059219
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/11/2020
• Initial Date FDA Received: 08/31/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2018
• 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
• Treatment: DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
• Patient Outcome(s): Required Intervention