inforMED
InjuryDTB

LASERDISH

Received Jul 6, 2026

Report 2017865-2026-14154 · MDR key 25713800

Device

Generic name

Permanent Pacemaker Electrode

Model number

033-444

Product problems

  • Break

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

UDI NOT AVAILABLE AS PRODUCT WAS MANUFACTURED ON OR BEFORE SEPTEMBER 23, 2014.

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT¿S RIGHT VENTRICULAR (RV) LEAD EXHIBITED PROBE OR INSULATION BREAKAGE. THE PROBE OR INSULATION BREAKAGE WAS CONFIRMED BY CHEST X-RAY. THE RV LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN GOOD CONDITION.