inforMED
InjuryDTD

pacemaker lead Adaptor

Received Jul 20, 2026

Report 2017865-2026-15213 · MDR key 25882153

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Product code (DTD)
Model (P2P758)

Device

Generic name

Pacemaker Lead Adaptor

Model number

P2P758

Product problems

  • Break
  • Under-Sensing
  • Low impedance

Patient

NA · Male

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE HOSPITAL. UPON INTERROGATION, IT WAS NOTED THAT THE RIGHT VENTRICULAR - RV LEAD EXHIBITED UNDERSENSING AND LOW PACING IMPEDANCE. DURING THE PROCEDURE, IT WAS NOTED THAT THE RV LEAD HAD INSULATION DAMAGE. THE RV LEAD WAS CAPPED AND REPLACED (B)(6) 2026. THE PATIENT WAS IN STABLE CONDITION BEFORE, DURING, AND AFTER THE PROCEDURE.