BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 12291589 · Received August 6, 2021

    Report

    Report Number
    3004209178-2021-12044
    Event Type
    Injury
    Date Received
    August 6, 2021
    Date of Event
    July 12, 2021
    Report Date
    August 17, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00643169630512
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H6. PATIENT CODE: E060110 WAS CORRECTED TO E2403. 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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM A COMPANY REPRESENTATIVE (REP) INDICATED THE CASE WAS CANCELLED FOR 2021-AUG-10. IT WAS NOT CURRENTLY RESCHEDULED. THE REP HAD NO FURTHER INFORMATION.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8780, LOT# SERIAL# (B)(4), IMPLANTED: (B)(6) 2020, PRODUCT TYPE: CATHETER. PRODUCT ID 8784, LOT# SERIAL# (B)(4), IMPLANTED: (B)(6) 2021, PRODUCT TYPE: CATHETER. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BY A HEALTHCARE PROVIDER (HCP) VIA COMPANY REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS RECEIVING UNKNOWN DRUG VIA IMPLANTABLE INFUSION PUMP. IT WAS REPORTED THAT THE REP WAS INFORMED THAT THE PATIENT HAS "FLIPPED HER PUMP" ON (B)(6) 2021. THE FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE WAS UNKNOWN. A CATHETER REVISION WAS SCHEDULED FOR (B)(6) 2021. THE ISSUE WAS NOT RESOLVED AT THE TIME OF REPORT. THE PATIENT'S STATUS AT THE TIME OF REPORT WAS ALIVE - NO INJURY. NO FURTHER INFORMATION. 2021-08-06 PC (HCP): ADDITIONAL INFORMATION WAS RECEIVED BY A HEALTHCARE PROVIDER (HCP) WHO REPORTED THAT THE PATIENT'S PUMP BECAME LOOSE IN THE POCKET AND WAS FLIPPING. THERE WERE NO KNOWN FACTORS THAT MAY HAVE LED TO THIS EVENT. THE HCP PLANS TO MOVE THE PUMP INTO A NEW POCKET ON (B)(6) 2021. THE HCP DENIED PLANNED CATHETER REVISION BUT NOTED THAT IF ANY KINKS/DAMAGE WERE FOUND WHEN MOVING THE PUMP INTO A NEW POCKET, THE HCP WOULD REPLACE IT AND RETURN TO MEDTRONIC FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1184938 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40 00643169630512

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention "SEE H10."