BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3201396 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-00151
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    February 21, 2012
    Report Date
    February 23, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8835, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: CATHETER: PRODUCT ID 8591-38, LOT# D12887, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT EXPERIENCED SOME PALPITATIONS AND EXCRUCIATING BURNING FOOT PAIN AFTER IMPLANT. THE PUMP WAS CHECKED AND IT LOOKED FINE. THE PAIN WAS MANAGED BY GIVING THE PATIENT A BOLUS FROM THE PUMP AND KETAMINE WAS ADMINISTERED. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR OVERNIGHT OBSERVATION. THE NEXT DAY THE PATIENT WAS SENT HOME. ¿IT WAS GETTING BETTER, BUT IT WAS STILL PAINFUL.¿ THE DRUG IN THE PUMP WAS INFUMORPH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303295 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR Hospitalization