MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) ASSURITY + DR RF; PULSE GENERATOR, PERMANENT, IMPLANTABLE

Model Number PM2260

Device Problems Pacing Problem (1439); Under-Sensing (1661)

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

Event Date 03/14/2024

Event Type  malfunction  

Event Description

It was reported that the patient presented in clinic for a follow up.Device interrogation revealed under sensing and mode switch on the pacemaker.No changes or interventions were performed.The patient was in stable condition.

Event Description

It was reported that the patient presented in clinic for a follow up.Device interrogation revealed under sensing that should have caused mode switch but did not occur on the pacemaker.Programming changes were performed to resolve the issue.The patient was in stable condition.

Manufacturer Narrative

Correction: b5 and h6 should have had programming changes noted.

• Brand Name: ASSURITY + DR RF
• Type of Device: PULSE GENERATOR, PERMANENT, IMPLANTABLE
• 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: 19047833
• MDR Text Key: 339508555
• Report Number: 2017865-2024-37760
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734507097
• UDI-Public: (01)05414734507097(10)P000031894(17)180131
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P880086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2018
• Device Model Number: PM2260
• Device Lot Number: P000031894
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/04/2024
• Supplement Dates Manufacturer Received: 04/08/2024; 04/11/2024
• Supplement Dates FDA Received: 04/09/2024; 04/12/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/22/2016
• 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