MAUDE Adverse Event Report: Abbott Medical (CRM-Sylmar) ENDURITY MRI; Implantable Pulse Generator, Pacemaker (Non-Crt)

Model Number	PM2172
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient presented to the hospital for a device follow-up with redness and swelling at the pocket site.Additionally, device interrogation revealed that the right atrial (ra) lead exhibited increased capture threshold resulting in loss of capture and decreased atrial sensing resulting in undersensing.During the lead revision procedure on (b)(6) 2026, chest x-ray confirmed that the ra lead had dislodged and there were also yellowish-white secretions within the device pocket.The pacemaker, ra lead and the right ventricular lead were explanted, and a new pacemaker system was implanted on the other side due to pocket infection.The physician stated that the infection was unrelated to the device and leads.The patient was in stable condition.
Additional Manufacturer Narrative
A device history record (dhr) review was performed and review of the sterilization records confirmed normal sterilization cycles for the products.The device met specifications prior to leaving abbott manufacturing facilities.The cause of infection could not be determined.

• Brand Name: ENDURITY MRI
• Common Device Name: Implantable Pulse Generator, Pacemaker (Non-Crt)
• Manufacturer (Section D): Abbott Medical (CRM-Sylmar); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): Abbott Medical (CRM-Sylmar); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: navpreet singh ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 50682088
• Report Number: 2017865-2026-18975
• Device Sequence Number: 16061222
• Product Code: LWP
• UDI-Device Identifier: 05414734509602
• UDI-Public: (01)05414734509602(10)P000251898(17)270831
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P140033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/09/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: PM2172
• Device Lot Number: P000251898
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/11/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown