BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 16872443 · Received May 4, 2023

    Report

    Report Number
    3004209178-2023-05975
    Event Type
    Injury
    Date Received
    May 4, 2023
    Date of Event
    April 24, 2023
    Report Date
    May 4, 2023
    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
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCT: PRODUCT ID 8709 LOT# SERIAL# (B)(4) IMPLANTED: (B)(6) 2004 EXPLANTED: OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 8709, SERIAL/LOT #: ((B)(4) UBD: 19-MAY-2006, UDI#: (B)(4). 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

    ON (B)(6) 2023 MPXR 1052692 (REP, HCP): INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT RECEIVING UNKNOWN BACLOFEN (2000MCG/ML, UNKNOWN DOSE) VIA AN IMPLANTABLE PUMP. THE INDICATIONS FOR USE WERE UNKNOWN. IT WAS REPORTED THAT THE SURGEON WAS UNABLE TO ASPIRATE THE CATHETER AT THE PUMP REPLACEMENT. THERE WAS A 2ML DISCREPANCY BETWEEN THE PUMP AND THE TABLET. THE TABLET REPORTED THAT THE PUMP SHOULD HAVE 13.3ML, BUT 15ML WAS WITHDRAWN FROM THE PUMP BY THE OPERATING ROOM NURSE. NO ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAD LED TO OR CONTRIBUTED TO THE ISSUE WERE REPORTED. A NEW CATHETER WAS PLACED AND THE OLD CATHETER WAS TIED OFF. IT WAS NOTED THAT THE HCP HAD NO FURTHER INFORMATION. THE PATIENT'S WEIGHT AND MEDICAL HISTORY WERE ASKED BUT UNKNOWN. THE PATIENT STATUS AT THE TIME OF THE REPORT WAS ALIVE WITH NO INJURY. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620918 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40 00643169508156

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention "SEE H10...."