MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ENDURITY MRI; Implantable pulse generator, pacemaker (non-CRT)

Model Number PM2172

Device Problem Pacemaker Found in Back-Up Mode (1440)

Patient Problem Discomfort (2330)

Event Date 02/27/2024

Event Type  malfunction  

Event Description

It was reported the patient presented in clinic for follow-up experiencing discomfort.Upon interrogation it was noted that the pacemaker was in back-up mode due to electromagnetic interference (emi).The pacemaker was successfully restored.The patient was recovering after the event.

Event Description

New information noted that the patient presented experiencing dizziness.The patient was in stable condition after reprogramming.

• Brand Name: ENDURITY MRI
• Type of Device: Implantable pulse generator, pacemaker (non-CRT)
• 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: 18927289
• MDR Text Key: 337949618
• Report Number: 2017865-2024-35270
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 05414734509602
• UDI-Public: 05414734509602
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P140033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: PM2172
• Device Lot Number: P000141334
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2022
• 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