BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 8275141 · Received January 24, 2019

    Report

    Report Number
    3004209178-2019-01655
    Event Type
    Malfunction
    Date Received
    January 24, 2019
    Report Date
    February 6, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00643169508156
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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 FROM A MANUFACTURER REPRESENTATIVE. IT WAS REPORTED THAT THE PATIENT WAS HAVING A DYE STUDY IN VIRGINIA ON (B)(6) 2019 AND WOULD FOLLOW UP WITH A NEUROSURGEON THERE IF NECESSARY. THERE WERE NO FURTHER COMPLICATIONS REPORTED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 8709SC, LOT#: N237078008, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: CATHETER. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 8709SC, SERIAL/LOT #: (B)(4), UBD: 11-DEC-2011, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS RECEIVING AN UNKNOWN DRUG AT UNKNOWN DOSE AND CONCENTRATION VIA INTRATHECAL DRUG DELIVERY PUMP. THE INDICATION FOR USE WAS NOT NOTED. IT WAS REPORTED THAT THE PATIENT RECENTLY MOVED TO NORTH CAROLINA. HE WAS IN THE MIDDLE OF TRANSFERRING TO A NEW MANAGING HEALTHCARE PROVIDER (HCP). THE CATHETER WAS LEAKING AND HE WAS HAVING WITHDRAWALS. THE PATIENT WAS INSTRUCTED TO GO TO THE EMERGENCY ROOM (ER). HE STATED HE WOULD GO ON THE SAME DAY, 2019-JAN-23. NO ENVIRONMENTAL, EXTERNAL, OR PATIENT FACTORS WERE REPORTED TO HAVE CAUSED THIS ISSUE. NO DIAGNOSTICS WERE DONE DUE TO THE PATIENT WAS NOT ESTABLISHED IN A HCP PRACTICE IN NORTH CAROLINA. THE DATE OF THE CATHETER LEAK WAS UNKNOWN. THE ISSUE WAS NO RESOLVED AND THE PATIENT WAS "ALIVE- NO INJURY." THERE WERE NO FURTHER COMPLICATIONS REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69048 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40 00643169508156

    Patients

    Seq Age Sex Outcome Treatment
    1