PACEL FLOW DIRECTED PACING CATHETER
Received Mar 27, 2025
Report 2182269-2025-00007 · MDR key 21707654
Device
Generic name
Electrode, Pacemaker, Temporary
Manufacturer
St. Jude MedicalModel number
401763Catalog number
401763
Lot number
10521773
Product problems
- Fracture
- Fracture
Patient
79 YR · Male
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A TEMPORARY PACEMAKER PROCEDURE IN (B)(6) 2025. THE PATIENT HAD TEMPORARY PACEMAKER WIRES TAPED TO THEIR LEG THAT ALLEGEDLY BROKE WHILE GETTING UP. IT APPEARS TO HAVE COME APART AT THE MIDDLE OF THE CATHETER NOT AT AN END OR HUB.