BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 5233811 · Received November 18, 2015

    Report

    Report Number
    3004209178-2015-23062
    Event Type
    Malfunction
    Date Received
    November 18, 2015
    Report Date
    October 28, 2015
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8731, LOT # B002148N06, IMPLANTED: (B)(6) 2003, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A COMPANY REPRESENTATIVE (REP) REGARDING A PATIENT RECEIVING AN UNKNOWN INTRATHECAL MEDICATION (UNKNOWN CONCENTRATION AND DOSE) VIA AN IMPLANTABLE INFUSION PUMP. THE INDICATION FOR USE WAS NOTED AS NON- MALIGNANT PAIN AND FAILED BACK SURGERY SYNDROME. THE PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. IT WAS REPORTED THAT A PUMP REFILL DISCREPANCY HAD OCCURRED DURING SERVICING. IT WAS NOTED THAT A MAJOR DISCREPANCY BETWEEN THE ACTUAL RESERVOIR VOLUME (ARV) AND EXPECTED RESERVOIR VOLUME (ERV) WERE FOUND AT REFILL ON AN UNKNOWN DATE. THE REPORTER DID NOT KNOW WHAT LEAD TO THE EVENT AND HOW THE ISSUE WAS IDENTIFIED. THE REPORTER WAS NOT AWARE OF ANY DIAGNOSTICS OR TROUBLESHOOTING THAT WAS PERFORMED. NO INTERVENTIONS/ACTIONS HAD TAKEN PLACE TO RESOLVE THE ISSUE, (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763305 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR