SYNCHROMED II

Report

Report Number: 3004209178-2018-24941
Event Type: Injury
Date Received: November 7, 2018
Date of Event: October 24, 2018
Report Date: September 24, 2019
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Product Code: LKK
UDI-DI: 00643169630505
PMA / PMN Number: P860004
Removal / Correction Number: Z-0497-2013
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 0

H3: ANALYSIS OF THE PUMP IDENTIFIED A FEEDTHRU ANOMALY DUE TO A FLUID BASED PIN SHORT AND A LEAKING PUMP TUBE OUTLET FITTING DUE TO DAMAGED OR MISSING O-RING. H6: THE PREVIOUSLY REPORTED EVALUATION CONCLUSION, METHOD, AND RESULT CODES NO LONGER APPLY. 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Additional Manufacturer Narrative · 0

MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. 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 AND HAS PROVIDED 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. 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 REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 0

ADDITIONAL INFORMATION WAS RECEIVED FROM AN HCP VIA A CLINICAL STUDY ON 2019-JAN-30. IT WAS REPORTED THAT DEVICE PRINTOUTS SHOWED MOTOR STALLS ON 2018-OCT-29 AT 10:54AM WITH RECOVERY AT 11:15AM AND AT 2:15PM WITH A RECOVERY AT 2:38PM, 2018-NOV-01 AT 4:06PM WITH RECOVERY AT 6:01PM AND AT 6:11PM WITH RECOVERY AT 6:28PM, 2018-NOV-02 AT 12:00AM WITH RECOVERY AT 12:55AM, AND 2018-NOV-06 AT 2:39PM WITH RECOVERY AT 12:18AM. THE PATIENT REPORTEDLY PRESENTED AT THE CLINIC WITH WITHDRAWAL SYMPTOMS ON (B)(6) 2018 THE NEXT PRINTOUT WITH LOGS WAS ON 2018-DEC-07 AT 7:20AM WITH LOGS BEGINNING ON 2018-NOV-08 AT 10:58AM WITH A MOTOR STALL RECOVERY. IT WAS NOTED THAT THE EVENT RESOLVED WITHOUT SEQUELAE ON 2018-NOV-06.

Description of Event or Problem · 0

ADDITIONAL INFORMATION WAS RECEIVED FROM AN HCP VIA A CLINICAL STUDY. IT WAS REPORTED THAT THE EVENT RESOLVED WITHOUT SEQUELAE ON (B)(6) 2018, (NOTE: THIS CONFLICTS WITH THE PREVIOUS REPORT THAT THE EVENT RESOLVED ON (B)(6) 2018, . ADDITIONAL MOTOR STALLS AND RECOVERIES WERE IDENTIFIED VIA PUMP LOGS AT THE FOLLOWING DATES AND TIMES: (B)(6) 2018, AT 11:32AM , WITH SPONTANEOUS RECOVERY ON (B)(6) 2018, AT 1:01PM; (B)(6) 2018, AT 1:35PM , WITH SPONTANEOUS RECOVERY ON (B)(6) 2018, AT 8:58PM; (B)(6) 2018, AT 9:48PM, WITH SPONTANEOUS RECOVERY ON (B)(6) 2018, AT 12:35AM; (B)(6) 2018, AT 7:55AM, WITH SPONTANEOUS RECOVERY ON (B)(6) 2018, AT 11:28PM; (B)(6) 2018, AT 10:36AM, WITH SPONTANEOUS RECOVERY ON (B)(6) 2018, AT 5:39PM; (B)(6) 2018, AT 601PM, WITH SPONTANEOUS RECOVERY ON (B)(6) 2018, AT 11:54PM; (B)(6) 2018, AT 8:12AM, WITH SPONTANEOUS RECOVERY ON (B)(6) 2018, AT 9:57AM; (B)(6) 2018, AT 8:17AM, WITH SPONTANEOUS RECOVERY ON (B)(6) 2018, AT 9:17AM; (B)(6) 2018, AT 7:41AM, WITH SPONTANEOUS RECOVERY ON (B)(6) 2018, AT 8:22AM; (B)(6) 2018, AT 5:28AM, WITH SPONTANEOUS RECOVERY ON (B)(6) 2018, AT 6:43AM; AND (B)(6) 2018, AT 7:39AM, WITH SPONTANEOUS RECOVERY ON (B)(6) 2018, AT 8:42AM.

Additional Manufacturer Narrative · 1