CATHETER PASSER

Description of Event or Problem

INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A COMPANY REPRESENTATIVE WHO REPORTED THAT DURING THE IMPLANT PROCEDURE, THE TUNNELING TOOL TAB BROKE WHEN REMOVING THE PLASTIC PIECE FROM HANDLE TO PULL IT THROUGH THE TUNNELER.

Additional Manufacturer Narrative

H3. THE RETURNED DEVICE WAS SUBJECTED TO A SERIES OF STANDARD TESTS THAT INCLUDE BUT IS NOT LIMITED TO VISUAL INSPECTION AND FUNCTIONAL TESTING. ANALYSIS IDENTIFIED THAT THE OBTURATOR WAS BROKEN. CONTINUATION OF D10: PRODUCT ID 977118 SERIAL# (B)(6) IMPLANTED: (B)(6) 2026 PRODUCT TYPE IMPLANTABLE NEUROSTIM ULATOR 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.