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 Over-Sensing (1438); Pacing Problem (1439); Under-Sensing (1661)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/11/2023

Event Type  malfunction  

Event Description

Related manufacturer reference number: 2017865-2023-95718.It was reported that the patient presented remotely to the clinic via merlin.Net transmission.Transmissions showed that there were automatic mode switch (ams) episodes from under-sensing were noted on the pacemaker and the right atrial (ra) lead.Programming changes were made via merlin.Net but was unsuccessful, as it resulted in far-r wave oversensing for both pacemaker and ra lead.There was a discussion to bring the patient into the clinic for programming changes, but not made yet.No further intervention was reported.The patient had no adverse consequences.

• 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: 18423104
• MDR Text Key: 331792492
• Report Number: 2017865-2023-95717
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 05414734510097
• UDI-Public: 05414734510097
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: P030035
• 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: 01/01/2024

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: 09/30/2023
• Device Model Number: PM3562
• Device Lot Number: P000143970
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/11/2023
• Initial Date FDA Received: 01/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2022
• 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