BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3518949 · Received December 13, 2013

    Report

    Report Number
    3007566237-2013-04022
    Event Type
    Injury
    Date Received
    December 13, 2013
    Report Date
    November 22, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PATIENT¿S PUMP ¿WENT BAD THE FIRST TIME¿ IT MADE A SOUND THAT WAS ¿VERY SIMILAR¿ TO A MORE RECENT EVENT WHEN THE PUMP WOULD GO OFF ABOUT EVERY ½ HOUR AND SOUNDED LIKE ¿DE-DO-DE-DO-DE-DO¿ (PLEASE REFER TO MANUFACTURER REPORT # 30042091 78-2013-23546). THE MEDICATION DELIVERED BY THE DEVICE SYSTEM WAS NOT PROVIDED. IT WAS LATER REPORTED THAT THE PUMP WAS REPLACED IN 2010. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652831 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00044 YR Required Intervention