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

Model Number PM3562

Device Problem Failure to Interrogate (1332)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/30/2022

Event Type  Injury  

Event Description

It was reported that the patient presented in clinic for follow up.The pacemaker was unable to be interrogated.The pacemaker was explanted and replaced.The patient was stable.

Manufacturer Narrative

Additional information notes device will not be returned.Update to h6 codes.

Event Description

New information notes product will not be returned.

• Brand Name: QUADRA ALLURE MP 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: 14091014
• MDR Text Key: 289185343
• Report Number: 2017865-2022-07775
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 05414734510097
• UDI-Public: 05414734510097
• Combination Product (y/n): N
• PMA/PMN Number: P030035
• 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
• Report Date: 06/20/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: PM3562
• Device Catalogue Number: PM3562
• Device Lot Number: A000104891
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/30/2022
• Initial Date FDA Received: 04/12/2022
• Supplement Dates Manufacturer Received: 06/17/2022
• Supplement Dates FDA Received: 06/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2021
• 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
• Treatment: QUARTET; TENDRIL
• Patient Outcome(s): Required Intervention