MAUDE Adverse Event Report: Abbott Medical (CRM-Sylmar) Aveir¿ Delivery Catheter; Leadless Pacemaker

Model Number	LSCD111
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)
Date of Event	07/30/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that after fixation, loss of capture and low current of injury was observed on the right ventricular (rv) leadless pacemaker (lp).The lp was repositioned with the delivery catheter; however, the loss of capture persisted in the new location.At this point, low blood pressure was observed.An ultrasound was performed and a pericardial effusion resulting in tamponade was observed.Pericardiocentesis was performed, and the blood pressure rose.The patient was transferred to a different hospital for treatment.The patient unfortunately passed away.Additional information was requested but not yet received.

• Brand Name: Aveir¿ Delivery Catheter
• Common Device Name: Leadless Pacemaker
• 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: 50355047
• Report Number: 2017865-2026-16599
• Device Sequence Number: 21390434
• Product Code: PNJ
• UDI-Device Identifier: 05415067036384
• UDI-Public: (01)05415067036384(10)11330601(17)270531
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P150035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/20/2026

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: LSCD111
• Device Catalogue Number: LSCD111
• Device Lot Number: 11330601
• 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: Not provided
• Initial Report FDA Received Date: 08/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/26/2026
• 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: Death
• Patient Sex: Unknown