BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2140970 · Received June 21, 2011

    Report

    Report Number
    3004209178-2011-04627
    Event Type
    Injury
    Date Received
    June 21, 2011
    Report Date
    May 26, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD EXPERIENCED A CHANGE IN THERAPY EFFECT AND A RETURN OF SYMPTOMS. AT THE END OF (B)(6), THE PATIENT HAS HAD A DRASTIC CHANGE IN THERAPY. THE PATIENT INDICATED THAT IT WENT FROM WORKING VERY WELL WITH A 90% REDUCTION IN PAIN TO MASSIVE PAIN IN THE SPINAL CORD, PRESSURE AT THE BASE OF THE SKULL AND NEAR HIS HEART. THE PATIENT REPORTED THAT ALMOST ALL OF THE PAIN HAS RETURNED. THE PATIENT HAD A CT MYELOGRAM ORDERED AND THE PUMP DOSE WAS INCREASED ON (B)(6) 2011. THERE WAS NO CHANGE IN SYMPTOMS DESPITE THE DOSE INCREASE. IT WAS NOTED THAT SINCE AUGUST, THE PATIENT HAS "TRIPPED AND FELL". THE PATIENT DID NOT FEEL THAT THIS WAS ANY BIG DEAL AND HE GOT RIGHT BACK UP BUT IT DID "JAR" HIM. IT WAS ALSO NOTED THAT THE PATIENT EXPERIENCED TICKS, HALLUCINATIONS, AND SEIZURES/MYOCLONIC EPISODES SINCE HE CAME OFF HIS ORAL OPIOID MEDICATION, WHICH HE WAS ON FOR 13 YEARS. THE PATIENT TAKES XANAX TO CONTROL THESE SYMPTOMS. THE PUMP WAS USED TO DELIVER DILAUDID AND BUPIVICAINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ACCESSORY: MODEL 8590-1, LOT# N257985| IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N260162001| EXPLANTED:| IMPLANTED: