BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2070151 · Received April 21, 2011

    Report

    Report Number
    3007566237-2011-02982
    Event Type
    Injury
    Date Received
    April 21, 2011
    Date of Event
    February 1, 2011
    Report Date
    April 7, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    TWO WEEKS AFTER THE SYSTEM WAS IMPLANTED, THE PT DEVELOPED AN INFECTION. THE PT TOOK ANTIBIOTICS AND THE INFECTION "SEEMED TO BE CLEARING UP." SHORTLY AFTER, THE PT NOTICED A GOLF-BALL-SIZED "BALL" NEAR THE PUMP POCKET. THE PHYSICIAN FLUSHED THE AREA AND STATED THERE WAS A BLOOD POCKET AND FLUID AROUND THE PUMP. THE NEUROSURGEON BELIEVED AN INFECTION WAS LOCALIZED TO THE SPINAL INCISION SITE, NEAR THE CATHETER PATHWAY. THE PUMP CONTAINED LIORESAL AT A DOSE OF 550 MCG/DAY. THE PLAN WAS TO REMOVE/EXPLANT THE CATHETER FROM THE AREA OF INFECTION, BUT LEAVE THE PUMP IMPLANTED AND RUN AT A MINIMUM RATE SO THE PUMP WOULD NOT NEED TO BE ACCESSED FOR REFILLS. THE PT WAS TO BE MANAGED ON ORAL BACLOFEN 20-30 MG TO AVOID WITHDRAWAL. IT WAS LATER REPORTED THE PUMP AND CATHETER WERE "COMPLETELY" EXPLANTED. THE DATE OF EXPLANT WAS NOT REPORTED. THE PLAN WAS TO IMPLANT ANOTHER PUMP AND CATHETER. AS OF (B)(6) 2011, THE PT WAS HOME AND HIS STATUS WAS "FAIR."

    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 23 YR Hospitalization| O CATHETER: MODEL 8596SC, LOT# N197150007| EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N274971023| EXPLANTED:| IMPLANTED:| IMPLANTED: