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

Model Number CD3369-40C

Device Problems Signal Artifact/Noise (1036); Loose or Intermittent Connection (1371); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 07/22/2020

Event Type  Injury  

Manufacturer Narrative

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 to the emergency room after receiving inappropriate high voltage therapy due to noise oversensing.The high voltage therapy was turned off and the patient was brought to the operating room for a revision procedure.During the surgery, the right ventricular lead fell out of the header of the implantable cardioverter defibrillator while removing the device from the pocket.The physician determined that this was a set screw anomaly and not related to the lead.The device was replaced and noise was no longer observed.The patient was in stable condition.

Manufacturer Narrative

The reported events of inappropriate shock and noise oversensing were confirmed in the laboratory.The stored electrogram was reviewed and noise was observed on the ventricular sensing channel.However, there were no viewable stored electrograms showing delivered therapies.The set screws were tested, and all set screws were able to be tightened down and secure test leads normally.It was reported that the right ventricular lead came out of the device header while removing the device from the patient.The cause of the reported event appeared consistent with poor set screw lead connection in the header that was procedure related.The device was tested on the bench, and no anomalies were 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: 10393953
• MDR Text Key: 202500832
• Report Number: 2017865-2020-11341
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734508346
• UDI-Public: 05414734508346
• 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: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• 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: CD3369-40C
• Device Catalogue Number: CD3369-40C
• Device Lot Number: A000090999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 78 YR
• Patient Weight: 72