HR HMS ACT CARTRIDGE

Additional Manufacturer Narrative

THIS REGULATORY REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION AS PART OF A CAPA ACTION. 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

MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF HR-ACT CARTRIDGES AND HMS RED CARTRIDGES, THE CUSTOMER REPORTED THAT THE PRODUCT WAS DELIVERED IN A DAMAGED, WET BOX. THE DEVICE WAS REPLACED. THERE WAS NO ADVERSE PATIENT EFFECT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WEREN'T ANY MISSING OR WRONG DEVICES OR COMPONENTS IN THE PACKAGE. THE OUTER BOX WAS DAMAGED, THE STERILE SEAL WAS DAMAGED AND PRODUCT WAS LEAKING.