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

Model Number CD3369-40C

Device Problems Failure to Deliver Shock/Stimulation (1133); Failure to Convert Rhythm (1540); Under-Sensing (1661)

Patient Problems Arrhythmia (1721); Death (1802)

Event Date 07/01/2020

Event Type  Death  

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

It was reported that the patient deceased.Upon interrogation of the patient¿s implantable cardioverter defibrillator, it was noted that the patient experienced six ventricular fibrillation episodes.Anti-tachycardia pacing (atp) was delivered for each episode however no high voltage shock therapy was delivered.It was suspected that the patient¿s device exhibited undersensing as one episode showed return to normal sinus rhythm after atp was delivered.

Manufacturer Narrative

The reported events of undersensing and no hv output were confirmed.Final analysis found that the patient's heart signal fell below the programmed sensing threshold.Functional tests revealed normal device behavior.

• 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
• 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: 10292985
• MDR Text Key: 199433174
• Report Number: 2017865-2020-09450
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734508346
• UDI-Public: 05414734508346
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030054
• 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,Followup
• Report Date: 11/23/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Model Number: CD3369-40C
• Device Catalogue Number: CD3369-40C
• Device Lot Number: A000071549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/06/2020
• Initial Date FDA Received: 07/17/2020
• Supplement Dates Manufacturer Received: 11/17/2020
• Supplement Dates FDA Received: 11/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 63 YR