BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1120750 · Received August 15, 2008

    Report

    Report Number
    2182207-2008-04991
    Event Type
    Injury
    Date Received
    August 15, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 23, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1151-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER.

    Description of Event or Problem · 1

    THE PT EXPERIENCED INCREASED PAIN. A MYELOGRAM WAS PERFORMED AND SHOWED A CATHETER TIP GRANULOMA. THE PT WAS GIVEN UNSPECIFIED ORAL MEDICATIONS AND THE PUMP DOSAGE WAS DECEASED. SURGERY IS BEING PLANNED TO PULL THE CATHETER BACK. THE PUMP WAS USED TO DELIVER HYDROMORPHONE, BUPIVICAINE AND CLONIDINE. ADD'L INFO HAS BEEN REQUESTED FROM THE HCP, A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 8637 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PROGRAMMER MODEL 8840 LOT # UNK| EXPLANTED| CATHETER MODEL 8709 LOT # J10961R39| IMPLANTED