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

Model Number PM2272

Device Problems Pacemaker Found in Back-Up Mode (1440); Therapy Delivered to Incorrect Body Area (1508); Inappropriate or Unexpected Reset (2959)

Patient Problem Discomfort (2330)

Event Date 11/10/2023

Event Type  malfunction  

Event Description

It was reported during in clinic follow up that the patient reported an uncomfortable twitching sensation across his chest.It was discovered that the device had gone into backup mode, though the root cause of the reset could not be determined.The device was successfully restored back to normal function.The patient was stable.

Manufacturer Narrative

Correction: previously reported as 'inappropriate or unexpected reset', now updated to 'pacemaker found in backup mode'.

• Brand Name: ASSURITY 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: 18275869
• MDR Text Key: 329847249
• Report Number: 2017865-2023-94007
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 05414734509589
• UDI-Public: 05414734509589
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P140033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/10/2024

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: 05/31/2024
• Device Model Number: PM2272
• Device Lot Number: P000157980
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/15/2023
• Initial Date FDA Received: 12/06/2023
• Supplement Dates Manufacturer Received: 01/10/2024
• Supplement Dates FDA Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2022
• 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