FDA Adverse Event Injury Summary report: N

SYNCHROMED II

MDR report key: 7710462 · Received July 23, 2018

Report

Report Number: 3004209178-2018-16381
Event Type: Injury
Date Received: July 23, 2018
Date of Event: June 28, 2018
Report Date: October 5, 2018
Manufacturer: MEDTRONIC NEUROMODULATION
Product Code: LKK
PMA / PMN Number: P860004
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8781 LOT# (B)(4). IMPLANTED: (B)(6) 2018, EXPLANTED: (B)(6) 2018. PRODUCT TYPE CATHETER. 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.

Description of Event or Problem · 0

ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE DATE THAT THE PUMP AND CATHETER WERE INITIALLY IMPLANTED WAS (B)(6) 2018. IT WAS REPORTED THAT THE CSF COLLECTION WAS FIRST NOTICED DAY 2 TO 3 POST-OP. IT WAS REPORTED THAT THE CATHETER WAS RE-CONNECTED IN THE 1ST EXPLORATION AND THEN THE CATHETER WAS REPLACED IN THE 2ND RE-EXPLORATION. IT WAS REPORTED THAT ANY CONTRIBUTING FACTORS THAT LED TO THE EVENT WAS THAT THE PATIENT WAS A SMOKER AND MAYBE THE COUGH WAS A RISK FACTOR. IT WAS REPORTED THAT THE PATIENT'S SPASTICITY WAS NOT IMPROVED AFTER THE 1ST SURGERY. THE SPASTICITY IMPROVED PARTIALLY AFTER THE 1ST-EXPLORATION AND RE-CONNECTION (2ND SURGERY, 10 DAYS POST-OP). THE SPASTICITY ONLY IM PROVED COMPLETELY AFTER THEY REPLACED THE CONNECTION WITH NEW CATHETER (3RD SURGERY, 3 WEEKS POST-OP). IT WAS REPORTED THAT ONLY REPLACED THE TIP OF THE PUMP SEGMENT WAS REPLACED AND THAT THEY USED A NEW CONNECTER TO CONNECT WITH THE INTRATHECAL ALREADY PLACED CATHETER, SO THE INTRADURAL PART WAS NOT CHANGED OR MODIFIED. IT WAS REPORTED THAT THE PUMP SEGMENT WAS REPLACED WITH THE NEW ON MONDAY (B)(6) 2018. IT WAS REPORTED THAT THE REPLACED PUMP SEGMENT WAS THROWN AWAY AND THUS WILL NOT BE RETURNED. NO FURTHER COMPLICATIONS WERE REPORTED AND/OR ANTICIPATED.