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

Model Number PM3242

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 10/20/2022

Event Type  Injury  

Event Description

It was reported that the pacemaker exhibited performance issue.The pacemaker was explanted and replaced.Patient status was not reported.

Manufacturer Narrative

Further information was requested but not received.

Manufacturer Narrative

The device was returned due to performance issue.The device was received with a battery voltage of 2.57 v.The device image was saved successfully and analyzed.No anomalies were noted.After all electrical tests performed, including thermal and mechanical stress testing the device exhibits normal characteristics with battery level 2.59 v.Longevity assessment was performed, and the device exceeded the device¿s projected longevity and is considered normal battery depletion.No anomalies were found.

• 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 16012098
• MDR Text Key: 305776379
• Report Number: 2017865-2022-49085
• Device Sequence Number: 1
• Product Code: NIK
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Model Number: PM3242
• Device Catalogue Number: PM3242
• Device Lot Number: A000015873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2015
• 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: QUARTET.; TENDRIL SDX.; TENDRIL SDX.
• Patient Outcome(s): Required Intervention
• Patient Sex: Male