MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ALLURE QUADRA RF CRT-P; NO MATCH

Model Number PM3242

Device Problems Premature Discharge of Battery (1057); No Pacing (3268); Interrogation Problem (4017)

Patient Problem Syncope/Fainting (4411)

Event Type  Injury  

Event Description

It was reported a patient's pacemaker presented with a transmission problem via merlin.Net.During initialization of the programmer session, the patient experienced syncope with loss of pacing.There was also an allegation of premature battery depletion.The pacemaker was explanted and replaced in a procedure on (b)(6) 2023.Post-procedure the patient status was unknown.

Manufacturer Narrative

The reported events of longevity anomalies and premature discharge of battery were not confirmed.Notification of no pacing output, and interrogation issues were confirmed.The device was received with unstable telemetry communication and no output.Analysis of the device image indicated the device was operated in high output mode, and an increase in pacing demands.With higher pacing outputs, battery¿s capacity is significantly reduced, and its voltage level is sensitive to variations in usage such as rate responsive and prolong telemetry interrogation.These conditions can result in fluctuation of battery voltage level measurements, which affects the longevity estimates.Electrical and mechanical tests performed including output verification did not identify any functional issues.Longevity assessment found the device was operating at end-of-service level, consistent with normal battery depletion.

• Brand Name: ALLURE QUADRA RF CRT-P
• Type of Device: NO MATCH
• 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: 18432140
• MDR Text Key: 331822704
• Report Number: 2017865-2024-00153
• 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
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Model Number: PM3242
• Device Lot Number: A000014583
• 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: 02/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2015
• 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: ATRIAL LEAD; LEFT VENTRICULAR LEAD; RIGHT VENTRICULAR (RV) LEAD
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male