CLIP ACC-1601 PUMP NGP 23L

Additional Manufacturer Narrative

CORRECTION/REMOVAL #: 2032227-060322-002-C. (B)(4). S/W VERSION: 3.18E UNIT PASSED DISPLACEMENT TEST. UNIT RECEIVED WITH CRACKED CASE (BATTERY TUBE), CRACKED CASE-CORNER OF BELT CLIP RAILS, AND BROKEN BELT CLIP RAILS. UNIT RECEIVED WITH BATTERY CAP CONTACT MISSING, HOWEVER UNIT RECEIVED WAS PROPERLY TESTED USING A TEST BATTERY CAP. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ""DEFECTS"" OR HAS ""MALFUNCTIONED"". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT."

Description of Event or Problem

MEDTRONIC RECEIVED INFORMATION THAT DAMAGE (PHYSICAL OR COSMETIC) OCCURRED. THERE WAS NO ADVERSE IMPACT OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT.