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

Model Number PM3222

Device Problems Premature Discharge of Battery (1057); Failure to Disconnect (2541)

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

Event Date 01/14/2022

Event Type  Injury  

Manufacturer Narrative

Implant date is not available.Further information was requested but not received.

Event Description

Related manufacturer reference number: 2017865-2023-22681.It was reported that the patient presented for a replacement procedure.It was noted that the left ventricular (lv) lead failed to be removed from the header of the pacemaker.The pacemaker and the lv lead were explanted and replaced.The patient was stable.

Event Description

New information received indicated that the device was explanted due to premature battery depletion.

Manufacturer Narrative

The reported event of premature discharge of battery was not confirmed, while the reported event of failure to remove lead from the header was confirmed.The device was above elective replacement indicator (eri) level upon receipt.Analysis of device image indicated that the device was within the normal range of operation.A longevity assessment was performed, and the device was found to have appropriate remaining longevity.Further analysis revealed the left ventricular setscrew was stripped due to improper insertion of torque driver into the hex cavity.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: 17084216
• MDR Text Key: 316794203
• Report Number: 2017865-2023-22679
• 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,Followup
• Report Date: 07/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: PM3222
• Device Catalogue Number: PM3222
• Device Lot Number: P000114042
• 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: 05/16/2023
• Initial Date FDA Received: 06/07/2023
• Supplement Dates Manufacturer Received: 06/20/2023; 07/27/2023
• Supplement Dates FDA Received: 06/21/2023; 07/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2020
• 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
• Patient Outcome(s): Required Intervention