MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) QUADRA ALLURE MP CRT-P; Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)

Model Number PM3562

Device Problems Pacemaker Found in Back-Up Mode (1440); Therapy Delivered to Incorrect Body Area (1508)

Patient Problem Discomfort (2330)

Event Date 03/12/2024

Event Type  malfunction  

Event Description

It was reported that patient presented in emergency department experiencing discomfort due to diaphragmatic stimulation.Upon interrogation, it was noted that the pacemaker was in backup vvi mode.The device was reprogrammed and restored successfully.Patient condition was stable.

• Brand Name: QUADRA ALLURE MP CRT-P
• Type of Device: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
• 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: 18988328
• MDR Text Key: 338730498
• Report Number: 2017865-2024-36919
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 05414734510097
• UDI-Public: 05414734510097
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: PM3562
• Device Lot Number: A000113988
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2021
• 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: QUARTET; TENDRIL; TENDRIL
• Patient Age: 84 YR
• Patient Sex: Male