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

Model Number PM2172

Device Problem Incorrect Measurement (1383)

Patient Problem Fatigue (1849)

Event Date 03/01/2023

Event Type  malfunction  

Event Description

It was reported during in clinic follow up that the pacemaker exhibited a diagnostic anomaly where device trend information was listed as unavailable on printed reports.The patient reported feelings of fatigue.The device will continue to be monitored.

• Brand Name: ENDURITY MRI
• 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: 16583722
• MDR Text Key: 311687961
• Report Number: 2017865-2023-14266
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 05414734509602
• UDI-Public: 05414734509602
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/21/2023

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: 11/30/2023
• Device Model Number: PM2172
• Device Catalogue Number: PM2172
• Device Lot Number: P000148476
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/01/2023
• Initial Date FDA Received: 03/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2022
• 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