BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3242527 · Received July 23, 2013

    Report

    Report Number
    3004209178-2013-12148
    Event Type
    Injury
    Date Received
    July 23, 2013
    Report Date
    July 16, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8703W, SERIAL # (B)(4), IMPLANTED: (B)(6) 1996, PRODUCT TYPE CATHETER; PRODUCT ID 8840, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS PATIENT EXPERIENCED WITHDRAWAL IN (B)(6) 2009 AS HIS PUMP RAN DRY. THE PATIENT¿S PHYSICIAN NO LONGER ACCEPTED HIS INSURANCE AND THE PATIENT WAS SEARCHING FOR ANOTHER MANAGING PHYSICIAN. REPORTEDLY, THE PATIENT¿S DEVICE WAS STILL ALARMING A MONTH LATER BUT THE PATIENT WAS NO LONGER IN WITHDRAWAL. IT WAS NOT KNOWN WHAT MEDICATION THIS DEVICE SYSTEM DELIVERED AT THE TIME OF THE EVENT. IT WAS FURTHER REPORTED THAT AT THE TIME HE EXPERIENCED WITHDRAWALS IN 2009 HE ALSO HAD DIABETES AND HIS RIGHT LEG WAS AMPUTATED AND HE LOST LEFT TOES AS WELL.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE AMPUTATION HAD NOTHING TO DO WITH THE THERAPY OR DEVICE. THE PATIENT IS A DIABETIC AND LOST THE PORTION OF THE RIGHT LEG AND LEFT TOES DUE TO POOR DIABETES MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343124 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Other