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

Model Number PM3140

Device Problem Connection Problem (2900)

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

Event Date 10/13/2022

Event Type  malfunction  

Event Description

It was reported that the patient presented for a generator change procedure for elective replacement indicator.During the procedure, it was noted that the pacemaker header was failing to connect to the lead.The pacemaker was not used.The physician continued with second pacemaker and completed the procedure.The patient was in stable condition.

Manufacturer Narrative

The reported event of ¿failure to connect¿ couldn¿t be confirmed.The device was above elective replacement indicator (eri) upon receipt.Device was never implanted.Analysis revealed unsuccessful connection of device is consistent with the type of header that requires the quadripolar lv and two bipolar leads, atrial and right ventricle, that don¿t match the pre-implanted leads.

• Brand Name: QUADRA ALLURE 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: 16309978
• MDR Text Key: 308915286
• Report Number: 2017865-2023-05241
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734507899
• UDI-Public: 05414734507899
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 03/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: PM3140
• Device Catalogue Number: PM3140
• Device Lot Number: P000128529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/30/2023
• Initial Date FDA Received: 02/07/2023
• Supplement Dates Manufacturer Received: 03/26/2023
• Supplement Dates FDA Received: 03/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/06/2021
• 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