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

Model Number PM2112

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

Patient Problems Fever (1858); Unspecified Infection (1930)

Event Date 08/20/2022

Event Type  Injury  

Event Description

Related manufacturer reference number: 2017865-2022-21163; related manufacturer reference number: 2017865-2022-21164.It was reported that the patient presented in the hospital due to recurrent fever and cough.Infection and endocarditis were discovered upon examination.The entire pacemaker system was explanted due to infection.The patient's condition was stable.

Manufacturer Narrative

A device history record (dhr) review was performed and all required manufacturing processes and inspection steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.Review of the sterilization records confirmed normal sterilization cycles for the products.The visual inspection was normal.Interrogation and preliminary test results were acceptable.No anomalies were noted.The cause of infection could not be traced to the device.

Manufacturer Narrative

Correction: section g8- the manufacturer report number should be 2017865-2022-21162 instead of 2017865-2022-20162.

• Brand Name: ACCENT DR
• 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: 15273513
• MDR Text Key: 298380747
• Report Number: 2017865-2022-21162
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P880086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: PM2112
• Device Lot Number: S000083258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2021
• 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
• Patient Outcome(s): Required Intervention