BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3802742 · Received May 9, 2014

    Report

    Report Number
    3004209178-2014-08807
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Report Date
    May 1, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1060-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2014, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT BELIEVED HE MIGHT HAVE RECEIVED A POCKET FILL IN THE PAST AT THE MANAGING HEALTHCARE PROVIDER¿S OFFICE. AT THE TIME OF REPORT, THERE WAS NO PATIENT INJURY. FOUR DAYS LATER, IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED BURNING AT THE POCKET SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280432 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1