BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 10218774 · Received July 1, 2020

    Report

    Report Number
    2182207-2020-00451
    Event Type
    Injury
    Date Received
    July 1, 2020
    Date of Event
    March 30, 2020
    Report Date
    July 13, 2020
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D11: PRODUCT ID 8709 LOT# J10901R56 SERIAL# IMPLANTED: (B)(6) 2001. EXPLANTED: PRODUCT TYPE CATHETER PRODUCT ID 8575 LOT# N081782 IMPLANTED: (B)(6) 2008. EXPLANTED: (B)(6) 2020. PRODUCT TYPE CATHETER. UBD: UNK; UDI#: (B)(4). THE EVALUATION CODE-CONCLUSION HAS BEEN UPDATED FOR THIS EVENT. 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 RECEIVED REPORTED THAT IT WAS UNKNOWN WHAT CAUSED THE DAMAGE, PER THE SURGEON IT WAS ALREADY DAMAGED WHEN THEY GOT INTO THE PUMP POCKET. IN REGARDS TO THE MEDICATION IN THE PUMP POCKET IT WAS CONFIRMED THAT PER THE SURGEON HE FELT THE CATHETER WAS LEAKING FLUID INTO THE PUMP POCKET. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS OR DIFFERENCE IN EFFICACY. THE PATIENT¿S CAREGIVER STATED SHE DID FEEL THE PATIENT¿S SPASTICITY HAD WORSENED IN THE PAST FEW MONTHS, HOWEVER COULD NOT GIVE AN EXACT TIME AS TO WHEN SHE NOTICED THIS. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED REGARDING THE EVENT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER (HCP) VIA THE MANUFACTURING REPRESENTATIVE (REP). IT WAS REPORTED THE NICK IN THE CATHETER WAS UNRELATED TO SURGERY. THE CATHETER WAS FOUND TO BE DAMAGED WHEN THE SURGEON WAS REPLACING THE PATIENT'S PUMP. THE SURGEON SAW THE DAMAGE AS SOON AS THEY GOT INTO THE POCKET. THE POCKET WAS FULL OF MEDICATION. THE ISSUE WAS RESOLVED BY REPLACING THE PUMP AND REPAIRING THE CATHETER.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709, SERIAL#: UNKNOWN, PRODUCT TYPE: CATHETER. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 8709, SERIAL/LOT #: UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTH CARE PROFESSIONAL (HCP) VIA A DEVICE MANUFACTURER REPRESENTATIVE REGARDING A PATIENT RECEIVING AN UNKNOWN DRUG AT AN UNKNOWN CONCENTRATION AND DOSE VIA AN IMPLANTABLE INFUSION PUMP. IT WAS REPORTED THAT THERE WAS A "NICK IN THE CATHETER" AND IT WAS BEING REPAIRED AT THE TIME OF THE CALL. NO OTHER INFORMATION WAS PROVIDED. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682369 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention "SEE H10...."