BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3150719 · Received June 6, 2013

    Report

    Report Number
    3004209178-2013-08748
    Event Type
    Injury
    Date Received
    June 6, 2013
    Report Date
    May 8, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_PTM_PROG. PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013. PRODUCT TYPE: CATHETER: PRODUCT ID 8835, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 8835, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED AN ¿8621 INCORRECT PUMP DETECTED¿ MESSAGE WAS ENCOUNTERED ON THE PATIENT¿S PERSONAL THERAPY MANAGER (PTM). IT WAS NO TED THE PATIENT HAD A PUMP PLACED AND THEN EXPLANTED DUE TO INFECTION. A NEW PUMP HAD BEEN IMPLANTED AND THE PATIENT HAD GOTTEN A NEW PTM WHICH THEN HAD GOTTEN WET. THE PATIENT WANTED TO USE THE PTM THEY HAD WITH THE INITIAL PUMP BUT WAS GETTING THE MESSAGE WHEN THE OLD PTM WAS ATTEMPTED TO BE ACTIVATED. IT WAS LATER REPORTED THE HEALTH CARE PROVIDER WAS ASSISTED WITH DECOUPLING THE PTM FROM THE EXPLANTED PUMP. IT WAS LATER REPORTED THE PATIENT WAS DOING FINE WHEN THEY WERE IN THE OFFICE DURING THE WEEK OF (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250785 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention