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 Problem Insufficient Information (3190)

Patient Problem Discomfort (2330)

Event Date 03/23/2024

Event Type  malfunction  

Manufacturer Narrative

Section e: the incident was reported by the patient, but the patient's following physician is dr.(b)(6).

Event Description

It was reported that the patient reported that their pacemaker is typically set at 60 bpm.On (b)(6) 2024 the patient stated they apparently experienced atrial fibrillation (af) and their pacemaker reset to 80 bpm.The patient stated they experienced discomfort due to the af which caused a great deal of discomfort and prompted a trip to the emergency room (er).The patient's concern seemed to be that if a pacemaker was set tp 60 bpm to maintain the heart at that rate increasing it during af would be counterintuitive.The patient was recovering.

• 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: 19174332
• MDR Text Key: 340947342
• Report Number: 2017865-2024-39519
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 05414734510097
• UDI-Public: (01)05414734510097(10)P000111554(17)220430
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: PM3562
• Device Lot Number: P000111554
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/22/2020
• 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 LEAD; TENDRIL LEAD; TENDRIL LEAD
• Patient Age: 76 YR
• Patient Sex: Male