BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3243504 · Received July 23, 2013

    Report

    Report Number
    3004209178-2013-12195
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Report Date
    July 3, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS PREVIOUSLY REPORTED IN MANUFACTURER REPORT # 3007566237-2013-01798 AND PERTAINS TO THIS EVENT: IT WAS REPORTED IN REGARDS TO ACTUAL RESERVOIR VOLUME AND EXPECTED RESERVOIR VOLUME THAT ¿USUALLY WHEN WE DO THE REFILLS, WE ALWAYS GET THE AMOUNT OR SOMETIMES OR A LOT OF TIMES, EVEN REFILLED IT MORE.¿ NEW INFORMATION: IT WAS REPORTED THAT A VOLUME DISCREPANCY OCCURRED. THE ACTUAL RESIDUAL VOLUME (ARV) WAS LESS THAN THE EXPECTED RESIDUAL VOLUME (ERV); ARV 1 MILLILITER (ML) AND ERV 2.7 ML. THE PATIENT WAS ASYMPTOMATIC AND IN THE PAST THERE HAD BEEN NO PREVIOUS ISSUES AS THIS WAS THE FIRST TIME THE PUMP WAS REFILLED. THIS DEVICE SYSTEM DELIVERED LIORESAL. IT WAS LATER REPORTED THAT THE HEALTHCARE PROVIDER (HCP) WAS REFERENCING THE SAME PATIENT. THE PATIENT HAD COME INTO THE CLINIC FOR HIS FIRST REFILL FOLLOWING PUMP IMPLANT IN DECEMBER, 2012. IT WAS THOUGHT THAT WHEN THE PUMP WAS FILLED ON THE BACK TABLE IT WAS POSSIBLE THAT ¿THEY WERE A LITTLE OFF; SOME MEDICATION MAY HAVE STILL BEEN IN THE SYRINGE." THE PATIENT HAD NO SYMPTOMS OR ISSUES AT ALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344095 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00012 YR