VALLEYLAB
Received Aug 14, 2025
Report 3026612481-2025-00002 · MDR key 22803706
Device
Product problems
- Appropriate Device Problem Term/Code Not Available
- Intermittent Energy Output
- Appropriate Device Problem Term/Code Not Available
- Intermittent Energy Output
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
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 DURING PROCEDURE, THE DEVICE STOPPED WORKING. THE PROCEDURE WAS CANCELLED THAT DAY.