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

Model Number PM3242

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 12/17/2021

Event Type  Injury  

Event Description

It was reported that the patient presented in clinic for non-cardiac reason.It was found that the patient had infection.The whole system including the pacemaker was explanted and a semi-permanent device was implanted temporarily.Patient condition was stable post procedure and was recovering from infection.

Manufacturer Narrative

A device history record (dhr) review was performed and review of the sterilization records confirmed normal sterilization cycles for the products.The device met specifications prior to leaving abbott manufacturing facilities.The product was returned and visual inspection, preliminary test and interrogation was normal.The cause of infection could not be traced to the device. .

• Brand Name: ALLURE QUADRA RF CRT-P
• 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: 13112726
• MDR Text Key: 282934264
• Report Number: 2017865-2021-40341
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734507912
• UDI-Public: 05414734507912
• 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,Followup,Followup
• Report Date: 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2016
• Device Model Number: PM3242
• Device Catalogue Number: PM3242
• Device Lot Number: A000002480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/17/2021
• Initial Date FDA Received: 12/29/2021
• Supplement Dates Manufacturer Received: 01/31/2022; 02/16/2022
• Supplement Dates FDA Received: 01/31/2022; 02/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2015
• 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; TENDRIL
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR
• Patient Sex: Male