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

Model Number CD3369-40Q

Device Problems Signal Artifact/Noise (1036); Intermittent Capture (1080); Failure to Capture (1081); Loose or Intermittent Connection (1371); Misconnection (1399); Capturing Problem (2891); High Capture Threshold (3266)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the patient presented for a lead revision.Prior to procedure, the competitor lead exhibited very high capture threshold and non-capture.The lead was replaced, and when the new lead was connected to the generator, it exhibited high capture threshold as well.However, the pacing systems analyzer showed low values when the lead was re-tested.The device was explanted and replaced, which resolved the capture issue.The patient was in stable condition.

Event Description

New information received noted that the device exhibited intermittent capture and noise on the right ventricular channel.Additionally, there was a set screw anomaly.

Manufacturer Narrative

The reported field event of threshold anomaly was not confirmed in the laboratory.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: 11013574
• MDR Text Key: 221731146
• Report Number: 2017865-2020-22876
• 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,Followup
• Report Date: 02/17/2021

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: 04/30/2022
• Device Model Number: CD3369-40Q
• Device Catalogue Number: CD3369-40Q
• Device Lot Number: A000096246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/25/2020
• Initial Date FDA Received: 12/15/2020
• Supplement Dates Manufacturer Received: 11/25/2020; 02/09/2021
• Supplement Dates FDA Received: 12/23/2020; 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 35 YR