SITUATE

Additional Manufacturer Narrative

CONCOMITANT PRODUCTS: 01-0034 - CONSOLE; RF ASSURE MODEL 200LD-V, LOT# L19FWC 01-0034 - CONSOLE; RF ASSURE MODEL 200LD-V, LOT# 14A4A 01-0035 - VERISPHERE, LOT# 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

ACCORDING TO THE REPORTER, DURING A NORMAL SPONTANEOUS VAGINAL DELIVERY (NSVD) PROCEDURE, THE TWO UNITS WERE SHOWING A POSITIVE DETECTION WHEN THERE WAS NO SPONGE PRESENT. AFTER THE VAGINAL BIRTH, THE REPORTER SCANNED THE PATIENT A FEW TIMES WITH ONE UNIT AND THEN BROUGHT IN ANOTHER UNIT AS WELL, TOTALING ABOUT 5 MINUTES. IT DELAYED THE PROCESS OF FINISHING UP WITH THE PATIENT AND ALLOWING HER TO GET BACK TO HER NEWBORN BABY. THE REPORTER USED ONE CONSOLE AND VERISPHERE. WHEN THAT DID NOT WORK, THEY USED ANOTHER SYSTEM WHICH INCLUDED ANOTHER CONSOLE AND VERISPHERE. A TOTAL OF TWO CONSOLES AND TWO VERISPHERE. A MANUAL COUNT WAS DONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.