MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ASSURA MP ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3369-40Q

Device Problem Misconnection (1399)

Patient Problem Undesired Nerve Stimulation (1980)

Event Date 05/15/2020

Event Type  malfunction  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.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

Manufacturer report number: 2017865-2020-07047.It was reported that the patient presented in clinic for follow up.Upon review, it was revealed that the right ventricular lead exhibited loss of capture, decrease in impedance, and decrease in sensing threshold.The physician suspected that the lead was perforated due to diaphragmatic stimulation from the right ventricular lead at high output.Lead perforation was verified with an echocardiogram exam.The patient was admitted for lead revision procedure on (b)(6) 2020.During procedure, the right ventricular lead was unscrewed from the implantable cardioverter defibrillator header.However, the physician had trouble unscrewing the right ventricular lead screw head.The right ventricular lead was removed and re-positioned in the right ventricular septum appropriately.Once the right ventricular lead was attached back to the device, the wrench would not catch into the screw.After multiple attempts and two separate wrenches, the physician determined that the screw was stripped and would not tighten.The implantable cardioverter defibrillator was explanted and replaced.The patient was stable post procedure.

Manufacturer Narrative

The reported field event of setscrew issue was verified in the lab.The right ventricular setscrew was found to have been completely backed out from its connector block as a result of unscrewing the setscrew too far.The setscrew inset was also found to have been corroded and stripped with septum debris lodged inside the hex cavity.The stripped setscrew was replaced with a test setscrew during functional testing in the lab.The other setscrews operated normally.Interrogation of the device revealed the device was above elective replacement indicator (eri) when received.Bench testing was performed; telemetry, sensing, pacing, patient notifier, hv shock, and hv impedance were tested and found to be normal.No device anomaly was found.

• Brand Name: QUADRA ASSURA MP ICD
• 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: 10117281
• MDR Text Key: 193915643
• Report Number: 2017865-2020-07048
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734508377
• UDI-Public: 05414734508377
• Combination Product (y/n): N
• PMA/PMN Number: P030054
• 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: 07/25/2020

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: 02/28/2022
• Device Model Number: CD3369-40Q
• Device Catalogue Number: CD3369-40Q
• Device Lot Number: A000094044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/15/2020
• Initial Date FDA Received: 06/03/2020
• Supplement Dates Manufacturer Received: 07/07/2020
• Supplement Dates FDA Received: 07/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR; DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
• Patient Age: 84 YR