PATIENT CABLE
Received Sep 29, 2025 · Event occurred Sep 10, 2025
Report 2182208-2025-04837 · MDR key 23164788
Device
Generic name
Cable, Transducer And Electrode, Patient, (inc
Manufacturer
Medtronic, Inc.Model number
5492VLCatalog number
5492VL
Lot number
2211120
Product problems
- Failure to Capture
- Loose or Intermittent Connection
- Failure to Capture
- Loose or Intermittent Connection
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- 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 PACING LEAD WAS LOOSE AND RESULTING IN LOSS OF CAPTURE BETWEEN PACING LEAD AND PATIENT CABLE TO THE EXTERNAL PULSE GENERATOR (EPG). TROUBLESHOOTING STEPS WERE TAKEN BY REPLACING WITH ANOTHER PATIENT CABLE AND ISSUE WAS RESOLVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
PRODUCT ANALYSIS : THE ANALYSIS COULD NOT CONFIRM THE CUSTOMER COMMENT THAT THE CONNECTION BETWEEN THE PATIENT CABLE AND THE PACING LEAD WAS LOOSE AND RESULTING IN LOSS OF CAPTURE BETWEEN PACING LEAD AND PATIENT CABLE TO THE EXTERNAL PULSE GENERATOR (EPG). THE CABLE PASSED ALL VISUAL INCOMING INSPECTION WITH NO ANOMALIES FOUND AND 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.