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

Model Number PM2272

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 03/25/2024

Event Type  Injury  

Event Description

Related manufacturer reference number: 2017865-2024-38331 it was reported the device is subject to the assurity and endurity pacemakers header anomaly advisory issued by abbott on 15 march 2021.The pacemaker was explanted prophylactically with no known malfunctions.Device interrogation revealed noise oversensing and low pacing impedance on the right ventricular (rv) lead.On (b)(6) 2024 the physician elected to cap and replace the rv lead.The patient was in stable condition.

Manufacturer Narrative

The device was returned due to advisory with no allegation of a malfunction.Visual inspection of the device and header attachment area did not find any anomalies.Electrical, longevity, and visual analysis was normal with no anomalies found.

• 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: 19102298
• MDR Text Key: 340100959
• Report Number: 2017865-2024-38330
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 05414734509589
• UDI-Public: (01)05414734509589(10)A000093219(17)210831
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/12/2024

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: 08/31/2021
• Device Model Number: PM2272
• Device Lot Number: A000093219
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/25/2024
• Initial Date FDA Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/10/2020
• 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
• Treatment: 2088TC/46
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female