MalfunctionDTB

PASSIVE PLUS

Received May 18, 2026

Report 2017865-2026-10414 · MDR key 25211739

Device

Generic name

Permanent Pacemaker Electrode

Manufacturer

Abbott Medical (crm-sylmar)

Model number

1246T

Product problems

Under-Sensing

Patient

NA · Unknown

Discomfort

Narrative

Additional Manufacturer Narrative

PRIMARY UNIQUE DEVICE IDENTIFICATION (UDI) NUMBER CANNOT BE PROVIDED AS A PRODUCT IDENTIFIER COULD NOT BE OBTAINED.

Description of Event or Problem

VOLUNTARY MEDWATCH RECEIVED STATES THAT THE PATIENT EXPERIENCED DISCOMFORT OCCASIONALLY AND THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDER-SENSING. NO INTERVENTIONS OR CHANGES WERE REPORTED, AND NO PATIENT CONSEQUENCES WERE REPORTED.