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

Model Number PM3242

Device Problems Difficult to Remove (1528); Contamination of Device Ingredient or Reagent (2901)

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

Event Date 11/02/2022

Event Type  malfunction  

Event Description

Related manufacturer reference number: 2017865-2022-45222.It was reported that the patient presented for a pacemaker change procedure.During the procedure, it was noted that the right ventricular (rv) lead was difficult to be removed from the pacemaker header, and subsequently a fluid contamination was seen between rv lead tip and pacemaker connector port.The header was cut, and the pacemaker was successfully explanted and replaced.The rv lead was reconnected to the new pacemaker.The patient was stable in condition.

Manufacturer Narrative

The reported event of unable to remove right ventricular lead could not be confirmed.The device was received from the field with right ventricular lead already removed from the pacemaker.Visual inspection noticed the device header severely damaged which prevented from performing additional testing.Further visual inspection noted some dried blood which is normal, but no contamination or foreign material detected.Review of the device image indicates the device voltage is at elective replacement level.Longevity assessment was performed, based on field settings and the device exceeded projected longevity indicating normal battery depletion.

• 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: 15786639
• MDR Text Key: 303840279
• Report Number: 2017865-2022-45220
• 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: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2016
• Device Model Number: PM3242
• Device Catalogue Number: PM3242
• Device Lot Number: 4723655
• 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: 12/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2014
• 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: QUARTETLEADS; TENDRIL STS LEADS
• Patient Age: 87 YR
• Patient Sex: Male