PATIENT CABLE
Received Apr 30, 2026 · Event occurred Mar 31, 2026
Report 2182208-2026-25170 · MDR key 25039958
Device
Generic name
Cable, Transducer And Electrode, Patient, (inc
Manufacturer
Medtronic, Inc.Model number
5492VLCatalog number
5492VL
Lot number
2310004
Product problems
- Material Integrity Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
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 CONNECTION BETWEEN THE PATIENT CABLE AND THE LEAD WAS LOOSE. IT WAS NOTED THAT THE PATIENT CABLE AND THE LEAD WERE UNABLE TO MAINTAIN A STABLE AND TIGHT CONNECTION, LEADING TO LOSS OF CAPTURE. THE PATIENT CABLE IS EXPECTED TO BE RETURNED FOR EVALUATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
PRODUCT ANALYSIS: ANALYSIS WAS UNABLE TO CONFIRM THE CUSTOMER COMMENT THAT THE CONNECTION BETWEEN THE PATIENT CABLE AND THE LEAD WAS LOOSE. THE CABLE PASSED VISUAL INCOMING INSPECTION WITH NO ANOMALIES NOTED. ALL CONTINUITY TESTS PASSED, AND NO INTERMITTENT OR SHORTED CONNECTIONS WERE 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.