BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1924848 · Received December 9, 2010

    Report

    Report Number
    3007566237-2010-10357
    Event Type
    Injury
    Date Received
    December 9, 2010
    Date of Event
    November 1, 2010
    Report Date
    December 2, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED CATHETER EROSION. THE REPORTER BELIEVED THAT THE CATHETER WAS EXPLANTED ON (B)(6) 2010. ONLY THE PUMP REMAINED IMPLANTED WITH THE DRUG BEING DELIVERED SUBCUTANEOUSLY. THE PUMP HAD CONTAINED MORPHINE, BUPIVICAINE AND DROPERIDOL. THE PUMP WAS REFILLED ON (B)(6) 2010, WITH PRESERVATIVE-FREE NORMAL SALINE (PFNS) AND PROGRAMMED TO MINIMUM RATE MODE. THE PT WAS BEING SUPPLEMENTED WITH A PAIN DRUG SKIN PATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT# N083097006