BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 8714245 · Received June 19, 2019

    Report

    Report Number
    3004209178-2019-11936
    Event Type
    Malfunction
    Date Received
    June 19, 2019
    Date of Event
    April 18, 2019
    Report Date
    June 19, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: A810, PRODUCT TYPE: SOFTWARE. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: A810. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A FOREIGN HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT RECEIVING INTRATHECAL BACLOFEN 1000 MCG/ML AT 1,481.1 MCG/DAY VIA AN IMPLANTABLE PUMP FOR CEREBRAL PALSY. IT WAS REPORTED THAT THE PATIENT¿S LAST PUMP REPLACEMENT OCCURRED ON (B)(6) 2018. ADDITIONALLY, NOTES FROM THE ATTACHED LOGS STATED 3.5CM WERE REMOVED ON (B)(6) 2018. THE PATIENT HAD A REFILL AND DOSE ADJUSTMENT ON (B)(6) 2018; HER DAILY DOSE WAS INCREASED FROM 339.8 MCG/DAY TO 359.8 MCG/DAY. THE PATIENT WAS REFILLED (AGAIN) ON (B)(6) 2019 WITH A CONCENTRATION OF 1000 MCG/ML AT 359.8 MCG/DAY (LOW RESERVOIR ALARM DATE (B)(6) 2019). IT WAS ALLEGED THAT THERE WAS A ¿WRONG ELECTIVE REPLACEMENT INDICATOR (ERI) ON THE REPORT¿. LOGS FROM (B)(6) 2019 SHOWED THE ESTIMATED REPLACEMENT DATE WAS ¿FEBRUARY 2025 ( <72 MONTHS)¿, AND LOGS FROM (B)(6) 2019 SHOWED THE ESTIMATED REPLACEMENT DATE WAS ¿JANUARY 2027 (<94 MONTHS)¿. NO PARAMETER CHANGES OR ADJUSTMENTS WERE MADE BETWEEN (B)(6) 2019 AND (B)(6) 2019 (TO THE BEST OF THE ACCOUNT AND MANUFACTURER REPRESENTATIVE¿S KNOWLEDGE), AND THE PATIENT¿S NEXT REFILL/VISIT WAS SCHEDULED FOR (B)(6) 2019. NO PUMP REPLACEMENT WAS PERFORMED. NO FURTHER COMPLICATIONS WERE REPORTED. REVIEW OF THE SESSION LOGS INDICATED THE EVENT WAS DUE TO PUMP MEMORY ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506017 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR