RHYTHMIA HDX
Received May 7, 2026 · Event occurred Apr 15, 2026
Report 2124215-2026-24939 · MDR key 25118013
Device
Generic name
Computer, Diagnostic, Programmable
Manufacturer
Boston Scientific CorporationModel number
M004RA71010Catalog number
M004RA71010
Product problems
- Loose or Intermittent Connection
- Communication or Transmission Problem
- Device Sensing Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE MAGNETIC LOCATION WAS LOST AND CATHETER COULD NOT BE VISUALIZED WHILE USING A LOCALIZATION GENERATOR CABLE, ADDITIONALLY ERROR 1105-2 AND 1113-2 WERE DISPLAYED. PICTURE PROVIDED SHOWED ERROR CODE 1318. NO PATIENT COMPLICATIONS OCCURRED. CASES WERE POSTPONED UNTIL REPLACEMENT. THERE IS NOT ANY INDICATION IF THE DEVICE WILL BE RETURNED. THIS EVENT IS BEING REPORTED FOR ABORTED/CANCELLED PROCEDURE WITH A PATIENT UNDER SEDATION.
Additional Manufacturer Narrative
A COMPLETE UDI IS NOT AVAILABLE FOR THIS DEVICE. ONCE THE CABLES ARE REMOVED FROM THEIR PACKAGING IT IS NO LONGER POSSIBLE TRACK THE LOT# FOR THE DEVICE SO SPECIFIC DEVICE INFORMATION CANNOT BE OBTAINED FROM THE FACILITY.