Unknown Temporary Pacing Electrode
Received May 23, 2026 · Event occurred May 14, 2026
Report 1018233-2026-03402 · MDR key 25265127
Device
Generic name
Temporary Pacing Electrode
Manufacturer
C.r. Bard Inc. (covington) -1018233Catalog number
UNK
Lot number
UNK
Product problems
- Positioning Failure
- Nonstandard Device
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(6). THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE REPORTED PRODUCT NUMBER IS UNKNOWN. THE UDI NUMBER FOR THIS PRODUCT IS NOT AVAILABLE. H11: SECTIONS A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.
Description of Event or Problem
IT WAS REPORTED BY CRITICAL CARE NURSES REPORTED IN AN ONLINE SURVEY THAT NO, THE TEMPORARY PACING ELECTRODE (TPE) CATHETER COULD NOT BE SUCCESSFULLY PLACED BECAUSE UNCLEAR IN RELATION TO BALLOON OR RIGHT HEART CURVE TPE, MENTIONING THAT THE DEVICE WAS USED FOR 7 DAYS.