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

Model Number PM3222

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 12/22/2023

Event Type  malfunction  

Event Description

It was reported that the patient presented to the hospital for a pulse generator upgrade, due to a worsening heart failure.During the procedure, it was noted that the set screw on the header of the pacemaker was too loose.The pacemaker was explanted and replaced.The patient had no adverse consequences.

Manufacturer Narrative

The reported event of the rv-setscrew and septum were pulled out of the header while trying to connect the lead was confirmed.Analysis revealed the user was not aligning the wrench tip to drop into the setscrew¿s hex shape inset.The user was forcing the corners of the wrench tip down into the inset walls which wedged the wrench tip into the walls sticking the setscrew to the wrench tip.The user did not know the setscrew was stuck to the wrench tip.When the user pulled the wrench out of the device the setscrew stuck to the wrench was pulled out with it along with the septum.This problem is related to the user¿s incorrect use of the torque wrench.The setscrew anomaly was consistent with having occurred during the procedure.

• Brand Name: ALLURE RF
• 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: 18500732
• MDR Text Key: 332893054
• Report Number: 2017865-2024-00583
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734507905
• UDI-Public: 05414734507905
• 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: 02/22/2024

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: 03/31/2020
• Device Model Number: PM3222
• Device Lot Number: A000066521
• 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: 12/22/2023
• Initial Date FDA Received: 01/12/2024
• Supplement Dates Manufacturer Received: 02/16/2024
• Supplement Dates FDA Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2018
• 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: LV LEAD; TENDRIL; TENDRIL
• Patient Age: 80 YR
• Patient Sex: Female
• Patient Weight: 71 KG