BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 17057095 · Received June 5, 2023

    Report

    Report Number
    3004209178-2023-08824
    Event Type
    Injury
    Date Received
    June 5, 2023
    Date of Event
    May 25, 2023
    Report Date
    June 4, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00643169530126
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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.

    Description of Event or Problem · 0

    2023-05-25 MPXR 1063053 (REP, HCP, CON): A PATIENT REPRESENTATIVE AND A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING AN IMPLANTED PUMP SYSTEM. THE PUMP WAS USED TO DELIVER GABLOFEN (BACLOFEN) 2000MCG/ML AT 290MCG/DAY. IT WAS REPORTED THAT, PER THE PATIENT'S SON, THAT AT THE LAST PUMP REFILL, THERE WAS MORE DRUG IN THE PUMP THERE WAS SUPPOSED TO BE. THERE WERE NO SYMPTOMS THAT THE REPORTER KNEW OF. ACCORDING TO THE PATIENT'S SON, A DYE STUDY WAS PERFORMED BY THE MANAGING PHYSICIAN BUT THEY WERE NOT CERTAIN OF THE RESULTS. THE PUMP WAS REPLACED ON (B)(6) 2023. IT WAS UNKNOWN IF ANY ADDITIONAL INTERVENTIONS/ACTIONS WERE TAKEN TO RESOLVE THE ISSUE. IT WAS UNKNOWN IF THERE WERE ANY ENVIRONMENTAL, EXTERNAL, OR PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. AT THE TIME OF THIS REPORT, THE ISSUE WAS RESOLVED AND THE PATIENT STATUS WAS "ALIVE-NO INJURY". THE PATIENT'S WEIGHT AND MEDICAL HISTORY WERE ASKED BUT WOULD NOT BE MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217652 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40 00643169530126

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention