BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 5586601 · Received April 19, 2016

    Report

    Report Number
    3004209178-2016-07708
    Event Type
    Malfunction
    Date Received
    April 19, 2016
    Report Date
    April 21, 2016
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RECENT FDA CODING CHANGES OFFER LIMITED OPTIONS FOR MEDICAL DEVICE EVALUATION CONCLUSION CODING. MEDTRONIC SELECTED CONCLUSION CODE BECAUSE, ALTHOUGH THE DEVICE WAS OPERATING WITHIN SPECIFICATIONS, MEDTRONIC MODIFIED THE SPECIFICATIONS MAKING THIS THE CLOSEST CODE AVAILABLE WITH RESPECT TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 8578, LOT# N140582, IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: CATHETER. PRODUCT ID: 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE: CATHETER. ANALYSIS OF THE CATHETER FOUND THE WHITE SILICONE BOOT OUT OF POSITION AS WELL AS CUTS OR TEARS CAUSING A LEAK IN THE CATHETER.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A DEVICE MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS RECEIVING AN UNKNOWN DRUG AT AN UNKNOWN DOSE AND CONCENTRATION VIA AN IMPLANTABLE PUMP FOR NON-MALIGNANT PAIN AND OTHER NON-MALIGNANT PAIN. IT WAS REPORTED THAT THE PUMP AND CATHETER WERE EXPLANTED DUE TO END OF LIFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241430 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1