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

Model Number PM2224

Device Problems Incorrect Measurement (1383); Wireless Communication Problem (3283)

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

Event Date 03/17/2023

Event Type  Injury  

Event Description

It was reported that a patient presented to clinic for follow up.Device interrogation revealed date elective replacement indicator (eri) prior to implant date.The implantable cardioverter defibrillator (icd) was also found with telemetry lockout.No changes or intervention were reported.

Event Description

Additional information received notes that pacemaker was explanted and replaced.There were no adverse consequences.

Manufacturer Narrative

Reported event of false eri and telemetry lockout were confirmed.The device was at elective replacement indicator (eri) level upon receipt.Analysis of device image indicates telemetry lockout occurred in the field was due to excessive rf telemetry usage in a short period of time.This lockout feature disables rf telemetry for a period to prevent battery drain of device.Session records provided show elective replacement indicator (eri) alert had been falsely triggered and end of service (eos) alert was detected.Further analysis performed found no anomaly.Longevity assessment was performed, and device was in the normal range of operation with appropriate remaining longevity.

• Brand Name: ACCENT MRI DR 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: 16628524
• MDR Text Key: 312206378
• Report Number: 2017865-2023-15956
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P140033
• 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,Followup
• Report Date: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2015
• Device Model Number: PM2224
• Device Lot Number: 4346904
• 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: 06/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/14/2013
• 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