NON-MEDTRONIC PRODUCT

Additional Manufacturer Narrative

CONCOMITANT PRODUCTS: UNKNOWN SURGICAL INNOVATIONS BO PRODUCT - UNK - SIBO, SERIAL# UNKNOWN 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 A LAPAROTOMY SPONGE WAS RETAINED IN THE PATIENT FOLLOWING A SURGICAL PROCEDURE, NECESSITATING A SECOND SURGERY TO RETRIEVE THE SPONGE. THE RETAINED SPONGE RESULTED IN EXTENDED THE PATIENT'S HOSPITALIZATION BY 3-4 DAYS. AN X-RAY WAS TAKEN TO ASSIST IN LOCATING THE RETAINED SPONGE. THE SPONGE COUNT AND SCAN WERE CORRECT AT THE END OF THE INITIAL PROCEDURE, AND THE PATIENT WAS INITIALLY TAKEN TO THE INTENSIVE CARE UNIT BUT HAD TO RETURN DUE TO COMPLICATIONS. THE SPONGE WAS FULLY RETRIEVED DURING THE SECOND SURGERY.

Description of Event or Problem

IT WAS REPORTED THAT POST-OPERATIVELY, A NON-MEDTRONIC LAPAROTOMY SPONGE WAS RETAINED IN THE PATIENT FOLLOWING A SURGICAL PROCEDURE, NECESSITATING A SECOND SURGERY TO RETRIEVE THE SPONGE. THE RETAINED SPONGE RESULTED IN EXTENDED PATIENT'S HOSPITALIZATION BY 3-4 DAYS. AN X-RAY WAS TAKEN TO ASSIST IN LOCATING THE RETAINED SPONGE AND THE PATIENT WAS INITIALLY TAKEN TO THE INTENSIVE CARE UNIT BUT HAD TO RETURN DUE TO COMPLICATIONS. THE SPONGE WAS FULLY RETRIEVED DURING THE SECOND SURGERY. IT WAS NOTED THAT THE SPONGE COUNT WAS CORRECT AND MACHINE READ A CORRECT COUNT AT THE END OF THE INITIAL PROCEDURE BUT DID NOT DETECT A SPONGE WAS IN THE PATIENT.

Additional Manufacturer Narrative

D10 CONCOMITANT PRODUCT: 01-0031, CONFORMPLUS II ANTENNA ARRAY BODY SCANNE (SERIAL#(B)(6)); 01-0043, CONSOLE; MODEL 200X (SERIAL#(B)(6)). ADDITIONAL INFORMATION: G3 CORRECTION: B5, D1, D4 (MODEL NUMBER AND CATALOG NUMBER). H6 ADDITIONAL REVIEW OF THE EVENT AND/OR ADDITIONAL INFORMATION RECEIVED SHOWS THAT THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT THE DEVICE IN THIS REPORT MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE IN THIS REPORT HAS MALFUNCTIONED. THEREFORE, THIS EVENT DID NOT AND DOES NOT MEET THE REPORTING REQUIREMENTS IN 21 CFR 803. 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.