BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 3202663 · Received July 2, 2013

    Report

    Report Number
    6000030-2013-00065
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    May 7, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8703W, LOT # L59328, IMPLANTED: (B)(6) 1999, EXPLANTED: (B)(6) 2012, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS GIVING THE PATIENT¿S HEART A VIRUS. THE PUMP HAD MALFUNCTIONED AND THE DOCTOR ¿STITCHED OVER THE STAPLES TO STOP IT FROM LEAKING.¿ ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2013 REPORTED THAT THE PUMP WAS EXPLANTED BECAUSE THE PATIENT CLAIMED THE INTRATHECAL MEDICATION WAS COMPLICATING HER CARDIAC PROBLEMS. THE REMOVAL OF THE CATHETER AND THE PUMP WAS SOLELY AT THE REQUEST OF THE PATIENT. THE PUMP WAS USED TO DELIVER DILAUDID AND BUPIVACAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301434 SYNCHROMED PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK RICE CREEK MFG 8617-18

    Patients

    Seq Age Sex Outcome Treatment
    1 00039 YR Required Intervention