BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3033800 · Received April 3, 2013

    Report

    Report Number
    3004209178-2013-04584
    Event Type
    Injury
    Date Received
    April 3, 2013
    Report Date
    March 6, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709, LOT# L73868, IMPLANTED: (B)(6) 2000, PRODUCT TYPE: CATHETER. PRODUCT ID: 8835, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PRODUCT ID: 8590-9, LOT# N317063, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 8578, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A VOLUME DISCREPANCY, AND FILLING DIFFICULTIES. THE PATIENT WENT TO THEIR HEALTHCARE PROVIDER (HCP) FOR A REFILL, AT WHICH TIME THERE WAS AN ACTUAL RESIDUAL VOLUME (ARV) OF 30 MILLILITERS (ML) OF DRUG ASPIRATED, WHEN THE EXPECTED RESIDUAL VOLUME (ERV) WAS ONLY 10 ML. WHEN THE HCP THEN TRIED TO REFILL THE PUMP WITH THE NEW DRUG, THE PUMP WOULD ONLY ALLOW 20 ML OF DRUG TO BE INJECTED INTO THE RESERVOIR. THE EVENT REQUIRED SURGICAL INTERVENTION AND THE DEVICE WAS SUBSEQUENTLY EXPLANTED AND REPLACED. THE SYMPTOMS RELATED TO THE EVENT WERE REPORTED AS THE PATIENT HAVING LESS THAN 50% THERAPY RELIEF. THE DRUG BEING DELIVERED VIA THE DEVICE WAS INFUMORPH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136477 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention