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

Model Number PM3242

Device Problem No Pacing (3268)

Patient Problems Discomfort (2330); Syncope/Fainting (4411)

Event Date 01/15/2023

Event Type  Injury  

Event Description

It was reported that the patient presented to the hospital after a syncopal episode that resulted in head trauma.An interrogation of the pulse generator revealed there was no low voltage pacing.The patient has scheduled for replacement and the device was explanted.The patient was recovering.

• 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: 16308044
• MDR Text Key: 308896692
• Report Number: 2017865-2023-05170
• 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
• Report Date: 02/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2015
• Device Model Number: PM3242
• Device Catalogue Number: PM3242
• Device Lot Number: 4648514
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2014
• 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: OPTISENSE LEAD; QUARTET LEAD; TENDRIL
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 80 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White