MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ASSURA MP ICD; No Match

Model Number CD3371-40QC

Device Problems Failure to Deliver Shock/Stimulation (1133); Pacing Problem (1439); Pacing Asynchronously (1441)

Patient Problem Arrhythmia (1721)

Event Date 07/22/2023

Event Type  Injury  

Event Description

It was reported that the patient was found to be unresponsive as an in-patient.The patient was noted to have had pacemaker mediated tachycardia (pmt).Programming changes were made.After the changes were made, the patient had a ventricular fibrillation (vf) episode with unsuccessful anti-tachycardia pacing (atp) therapy attempts, an unsuccessful high voltage (hv) 36j shock, and a successful reversion to sinus rhythm with a 40j shock.The patient had another episode of pmt prior to the ventricular tachycardia (vt)/vf.There was an episode of automatic mode switch (ams) detected prior to the pmt and vt, which showed competitive atrial pacing and repetitive non-reentrant ventriculoatrial synchrony (rnrvas), which the patient appeared to have been asymptomatic.There were no adverse health consequences to the patient.

• Brand Name: QUADRA ASSURA MP ICD
• Type of Device: No Match
• 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 17565697
• MDR Text Key: 321356783
• Report Number: 2017865-2023-38565
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CD3371-40QC
• Device Lot Number: A000127330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other