MAUDE Adverse Event Report: ABBOTT ENDURITY MRI PACEMAKER, SR; Implantable pulse generator, pacemaker (non-CRT)

Model Number PM1172

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

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

Event Date 11/06/2023

Event Type  malfunction  

Event Description

It was reported that the device was in backup mode.The device was restored to normal function to resolve the event and the patient was stable.

• Brand Name: ENDURITY MRI PACEMAKER, SR
• Type of Device: Implantable pulse generator, pacemaker (non-CRT)
• Manufacturer (Section D): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ABBOTT; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 18172371
• MDR Text Key: 328556417
• Report Number: 2017865-2023-72712
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 05414734509596
• UDI-Public: 05414734509596
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: P140033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: PM1172
• Device Lot Number: P000153426
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1