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

Model Number CD1411-36Q

Device Problems Pacing Problem (1439); Failure to Sense (1559); Defective Device (2588); Appropriate Term/Code Not Available (3191)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/29/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The results/methods and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported that the patient presented in clinic for a follow up.Upon examination, it was discovered that the right ventricular lead was losing sensing when the patient raised her arm 90 degrees.On (b)(6) 2020, the patient was brought to the hospital for a lead revision procedure.While prepping the surgical site, it was noted that the loss of sensing which precipitated ventricular pacing occurred while the hospital staff was pressing on the implantable cardioverter defibrillator.The incision was opened and the device was removed.A tug test was performed to demonstrate the setscrew was securely tightened at the initial implant.A photograph was obtained showing the pin correctly inserted into the device header.The physician manipulated the header and loss of sensing and loss of ventricular pacing were observed.The right ventricular lead was disconnected from the device and threshold values were checked on a pacing system analyzer (psa).All thresholds were appropriate.The physician then manipulated the exposed portion of the lead but no loss of sensing was observed on the psa.The physician concluded that the issue was the header of the device.A new device was implanted and tested.No loss of sensing was noted on the new device.The pocket was then closed and the patient was discharged home after the procedure.

Manufacturer Narrative

The reported header anomaly, failure to sense, and pacing problems were not confirmed in the laboratory.The device was tested on the bench, and no anomalies were found.

• 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: 11178720
• MDR Text Key: 227074709
• Report Number: 2017865-2021-02197
• 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
• Report Date: 03/26/2021

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: 10/31/2021
• Device Model Number: CD1411-36Q
• Device Catalogue Number: CD1411-36Q
• Device Lot Number: A000088108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/29/2020
• Initial Date FDA Received: 01/15/2021
• Supplement Dates Manufacturer Received: 03/09/2021
• Supplement Dates FDA Received: 03/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 30 YR