BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 3971642 · Received July 31, 2014

    Report

    Report Number
    3007566237-2014-02140
    Event Type
    Injury
    Date Received
    July 31, 2014
    Report Date
    July 10, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITATION: PRODUCT ID 8709SC, SERIAL# (B)(4), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) ON (B)(6) 2014 WITH ¿THE SAME SYMPTOMS¿. THE PATIENT EXPERIENCED ALTERED MENTAL STATUS, MUSCLE CRAMPING, MUSCLE TWITCHING AND HALLUCINATIONS. THE SUDDEN ONSET OF SYMPTOMS WAS RELIEVED WITH ORAL BACLOFEN. THE PATIENT DID NOT HAVE A FEVER. THE PUMP WAS DELIVERING FENTANYL AND LIORESAL. (PLEASE SEE MANUFACTURER REPORT # 3004209178-2014-13729 REGARDING ¿THE SAME SYMPTOMS¿) ADDITIONAL INFORMATION REPORTED THE PATIENT EXPERIENCED RIGIDITY, SHAKINESS AND ¿HEARING COUNTRY MUSIC¿. THE PATIENT RECOVERED WITHOUT PERMANENT IMPAIRMENT.

    Description of Event or Problem · 1

    THE "SAME SYMPTOMS" THE PATIENT EXPERIENCED WERE INCREASED PAIN, NUMBNESS, AND NAUSEA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447307 SYNCHROMED PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR Other