PATIENT CABLE
Received Feb 12, 2026 · Event occurred Dec 16, 2025
Report 2182208-2026-02372 · MDR key 24321809
Device
Generic name
Cable, Transducer And Electrode, Patient, (inc
Manufacturer
Medtronic, Inc.Model number
5492VLCatalog number
5492VL
Lot number
2111096
Product problems
- Material Integrity Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
PRODUCT ANALYSIS :ANALYSIS WAS ABLE TO CONFIRM THE CUSTOMER'S COMMENT THAT THE PATIENT CABLE WAS DAMAGED, SPECIFICALLY BROKEN AT THE END, LEAVING THE WIRE EXPOSED. IT WAS NOTED THAT THE OUTSIDE CABLE INSULATION WAS OPEN FROM THE HEART LEAD CONNECTOR, EXPOSING INTERNAL RED AND BLACK WIRES. ALL CONTINUITY TESTS WERE OKAY, AND NO INTERMITTENT OR SHORTED CONNECTIONS WERE OBSERVED. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
Additional Manufacturer Narrative
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT CABLES DID NOT WITHSTAND MORE THAN 20 CYCLES OF STEAM STERILIZATION, WHICH WAS USED AS THE CLEANING PROCEDURE. IT WAS NOTED THAT THE CABLES WERE DAMAGED, SPECIFICALLY BROKEN AT THE END, LEAVING THE WIRE EXPOSED. THERE WAS NO PATIENT INVOLVEMENT.