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

Model Number PM3222

Device Problem Failure to Disconnect (2541)

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

Event Date 01/14/2022

Event Type  malfunction  

Event Description

Related manufacturer reference number: 2017865-2023-20769.It was reported that during a routine generator change, the left ventricular (lv) lead could not be disconnected from the pacemaker.The physician explanted and replaced the lv lead and the pacemaker.The patient was discharged from the hospital after the procedure.

Manufacturer Narrative

The reported event of the lv-lead was stuck in the device header was confirmed.The pacemaker was returned for analysis.Analysis revealed the lv-setscrew had been stripped by the user of the torque wrench.The user was making incorrect wrench insertions causing the stripping of the setscrew inset.After the inset is stripped the setscrew can no longer be untightened with the wrench.Lab testing found that the setscrew could be untightened with normal force once it was engaged with tools.The lv-lead was then removed normally.The problem is related to the user¿s incorrect use of the wrench.The setscrew anomaly was consistent with having occurred during the procedure.

• Brand Name: ALLURE RF
• 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: 17008084
• MDR Text Key: 316007130
• Report Number: 2017865-2023-20768
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734507905
• UDI-Public: 05414734507905
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/07/2023

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: 04/30/2022
• Device Model Number: PM3222
• Device Catalogue Number: PM3222
• Device Lot Number: P000110914
• 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: 05/11/2023
• Initial Date FDA Received: 05/25/2023
• Supplement Dates Manufacturer Received: 07/19/2023
• Supplement Dates FDA Received: 08/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2020
• 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