MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ALLURE RF; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number PM3222

Device Problem Pacemaker Found in Back-Up Mode (1440)

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

Event Date 07/06/2022

Event Type  malfunction  

Event Description

It was reported that the patient presented remotely via merlin.Net.Upon review, it was discovered that the pacemaker was in backup operation.It was noted that the device unpaired to the transmitter and attempted pairing.Read error message was displayed per the clinic.Programming changes were performed, and the device was reset.The patient was in stable condition.

• Brand Name: ALLURE RF
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• 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: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 15099281
• MDR Text Key: 303420547
• Report Number: 2017865-2022-15996
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734507905
• UDI-Public: 05414734507905
• 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: Other
• Type of Report: Initial
• Report Date: 07/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: PM3222
• Device Catalogue Number: PM3222
• Device Lot Number: A000040043
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2017
• 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: LV LEAD; RA LEAD; RV LEAD
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 118 KG