MalfunctionDTB
BI,TINED,IS-1, J ,ENDO LEAD
Received Jul 13, 2026 · Event occurred Jun 23, 2026
Report 2017865-2026-14747 · MDR key 25808194
Device
Generic name
Permanent Pacemaker Electrode
Manufacturer
Abbott Medical (crm-sylmar)Model number
1222T/52Product problems
- Over-Sensing
- Pacing Problem
Patient
89 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
UDI NOT AVAILABLE AS PRODUCT WAS MANUFACTURED ON OR BEFORE (B)(6) 2014.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED REMOTELY VIA MERLIN.NET. IT WAS NOTED THAT THE RIGHT ATRIAL LEAD EXHIBITED NOISE OVER-SENSING WHICH RESULTED IN INAPPROPRIATE MODE SWITCH. NO INTERVENTION WAS PERFORMED. THE PATIENT REMAINED IN A STABLE CONDITION.