BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4133757 · Received October 1, 2014

    Report

    Report Number
    3007566237-2014-02807
    Event Type
    Injury
    Date Received
    October 1, 2014
    Report Date
    September 12, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8551, LOT# 60747972, IMPLANTED: (B)(6) 2005, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 8709, LOT# L74355, IMPLANTED: (B)(6) 2000, EXPLANTED: (B)(6) 2012, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S PUMP WAS REPLACED A COUPLE OF YEARS PRIOR TO THIS REPORT BECAUSE THERE WAS A LARGE SEROMA THAT BURST ON THE OUTSIDE OF HER PUMP AND THE PATIENT EXPERIENCED AN INFECTION. THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN AND DILAUDID. THE PATIENT¿S MEDICAL STATUS PRIOR TO THE EVENT, POSSIBLE DEVICE OR USE ISSUES, CAUSE OF THE INFECTION, TROUBLESHOOTING/DIAGNOSTICS, AND FINAL PATIENT OUTCOME WERE NOT REPORTED. FURTHER FOLLOW-UP WAS CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611663 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863720

    Patients

    Seq Age Sex Outcome Treatment
    1 00044 YR Required Intervention