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

Model Number PM3262

Device Problems Loose or Intermittent Connection (1371); Failure to Disconnect (2541)

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

Event Date 05/24/2023

Event Type  malfunction  

Event Description

It was reported that the patient presented in the operation room for a generator change.During the procedure, it was noted that the right ventricular (rv) lead and the right atrial (ra) lead failed to be removed from the pacemaker's header.The rv lead and ra lead were successfully removed from the pacemaker's header using another wrench and the pacemaker was explanted.There were no patient consequences.

Manufacturer Narrative

Correction: section b5 ¿ should have said "it was reported that the patient presented in the operation room for a generator change.During the procedure, it was noted that the right ventricular (rv) lead and the right atrial (ra) lead failed to be removed from the pacemaker's header using hex wrench due to unspecified fitting issue.The rv lead and ra lead were successfully removed from the pacemaker's header using another wrench and the pacemaker was explanted.There were no patient consequences." rather than "it was reported that the patient presented in the operation room for a generator change.During the procedure, it was noted that the right ventricular (rv) lead and the right atrial (ra) lead failed to be removed from the pacemaker's header.The rv lead and ra lead were successfully removed from the pacemaker's header using another wrench and the pacemaker was explanted.There were no patient consequences.".

Event Description

It was reported that the patient presented in the operation room for a generator change.During the procedure, it was noted that the right ventricular (rv) lead and the right atrial (ra) lead failed to be removed from the pacemaker's header using hex wrench due to unspecified fitting issue.The rv lead and ra lead were successfully removed from the pacemaker's header using another wrench and the pacemaker was explanted.There were no patient consequences.

• Brand Name: QUADRA ALLURE MP 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: 17028600
• MDR Text Key: 316201019
• Report Number: 2017865-2023-22007
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734509091
• UDI-Public: 05414734509091
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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,Followup
• Report Date: 06/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Model Number: PM3262
• Device Catalogue Number: PM3262
• Device Lot Number: P000021976
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2015
• 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 LEAD; TENDRIL LEAD; TENDRIL LEAD