BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 5049596 · Received September 2, 2015

    Report

    Report Number
    3004209178-2015-17133
    Event Type
    Malfunction
    Date Received
    September 2, 2015
    Report Date
    August 10, 2015
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8590-1, LOT# N100014, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORTER WAS UPDATED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A COMPANY REPRESENTATIVE REGARDING A PATIENT RECEIVING AN UNKNOWN DRUG VIA AN IMPLANTABLE PUMP. THE IN DICATIONS FOR USE WERE NOTED AS NON-MALIGNANT PAIN, LUMBAR RADICULOPATHY AND FAILED BACK SYNDROME-OTHER. THE PATIENT HAD A SPINE SURGERY LAST WEEK AND THE SURGEON DISCONNECTED THE CATHETER FROM THE PUMP. THE PUMP WAS PROGRAMMED TO MIN RATE AT THAT TIME. THE PATIENT WAS CURRENTLY NOT RECEIVING THERAPY FROM THE INFUSION SYSTEM. OUTCOME NOT REPORTED. FURTHER FOLLOW-UP WAS BEING CONDUCTED TO OBTAIN INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURING REPRESENTATIVE REPORTED THAT THE INITIAL REPORTER OF THIS EVENT WAS THE HEALTH CARE PROVIDER (HCP), AND WAS REPORTED TO MANUFACTURING REPRESENTATIVE ON (B)(6) 2015.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION SHOULD HAVE BEEN SUBMITTED ON THE INITIAL REPORT: THE INDICATIONS FOR USE WERE FAILED BACK SYNDROME AND LUMBAR RADICULOPATHY. THE REPORTER WAS NOT AWARE OF ANY ADVERSE EVENTS ASSOCIATED TO THE CATHETER BEING DISCONNECTED. THE CAUSE OF THE SPINAL SURGERY AND THE DISCONNECT WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583437 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR