PATIENT CABLE
Received Jun 17, 2025 · Event occurred May 20, 2025
Report 2182208-2025-02904 · MDR key 22217239
Device
Generic name
Cable, Transducer And Electrode, Patient, (inc
Manufacturer
Medtronic, Inc.Model number
5492ALCatalog number
5492AL
Lot number
2208067
Product problems
- Connection Problem
- Connection Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THE PATIENT CABLE WAS RETURNED AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING THE MANUFACTURER'S ANALYSIS. THERE WAS NO PATIENT INVOLVEMENT.
Additional Manufacturer Narrative
PRODUCT ANALYSIS: IT WAS DETERMINED DURING ANALYSIS THAT THE PATIENT CABLE'S HEART LEAD CONNECTOR POSITIVE KNOB ASSEMBLY WAS BROKEN OFF. ALL CONTINUITY TESTS WERE PASSED. THERE WERE NO INTERMITTENT OR SHORTED CONNECTIONS FOUND. 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.