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

Model Number CD3371-40QC

Device Problems Therapy Delivered to Incorrect Body Area (1508); Data Problem (3196); Interrogation Problem (4017)

Patient Problem Discomfort (2330)

Event Date 02/13/2023

Event Type  malfunction  

Manufacturer Narrative

The reported event of a cyclical redundancy check (crc) error was confirmed.The device¿s parameter settings were unexpectedly changed.Based on the information provided, the exact cause of the error is not able to be determined.

Event Description

Related manufacturer report number: 2017865-2023-11639.It was reported that phrenic nerve stimulation was observed on a recently implanted cardiac resynchronization therapy (crt) device.Upon interrogation an error message was observed requesting confirmation whether this was an older model and a reset.A cyclical redundancy check (crc) error was suspected.A reset was completed and the device restored to nominal settings.This turned therapies off and changed the pacing mode and left ventricular (lv) vector leading to further phrenic nerve stimulation.Reprogramming of therapies back on was completed.Additional issues communicating with the (crt) device were observed the following day on (b)(6) 2023.An attempt to change the lv pacing vector resulted in a frozen programmer screen and the programmer had to be shut down to re-interrogate the device.It was also reported that noise resulting in auto mode switching (ams) episodes had previously been observed on the patient's atrial lead.The physician chose not to make any changes to the atrial lead.Further information during interrogation on (b)(6) 2023 indicated normal (crt) device function.The error message was thought to be a one-off and the (crt) device was expected to behave normally.Repositioning of the non-abbott left ventricular (lv) lead was discussed due to continued peripheral nervous system stimulation.Programming changes were made to the best possible limits.

• 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 16475742
• MDR Text Key: 310588760
• Report Number: 2017865-2023-11638
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: Physician
• Type of Report: Initial
• Report Date: 03/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CD3371-40QC
• Device Lot Number: A000129031
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2022
• 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
• Treatment: MEDTRONIC LV LEAD 479-88 CM, SN: (B)(4).