BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 5405277 · Received February 2, 2016

    Report

    Report Number
    3004209178-2016-01387
    Event Type
    Injury
    Date Received
    February 2, 2016
    Report Date
    January 6, 2016
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). HIGH PITCHED VOICE LIKE A WOMAN THAT IS SQUEAKY.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT RECEIVING INTRATHECAL DILAUDID (DOSE AND CONCENTRATION UNKNOWN) VIA AN IMPLANTED PUMP SYSTEM. THE PATIENT MENTIONED UNDESIRED SIDE EFFECTS WITH THE USE OF DILAUDID. THE PATIENT'S MEDICATION WAS BEING SLOWLY TITRATED UP TO ACHIEVE AN OPTIMAL THERAPY EFFECT. AT ONE POINT IT WAS INCREASED TOO MUCH, AND THE PATIENT THE PATIENT BEGAN HAVING DEPRESSION AND SUICIDAL THOUGHTS. THE PATIENT ALSO REPORTED HAVING A HIGH-PITCHED VOICE LIKE A WOMAN THAT WAS SQUEAKY. THE PATIENT'S DEPRESSION WAS ALWAYS PRESENT, BUT IT GRADUALLY GOT WORSE WITH EACH DOSAGE INCREASE. THE PATIENT ADMITTED THEMSELVES TO THE HOSPITAL DUE TO THE SUICIDAL THOUGHTS. ONCE THE MEDIATION WAS LOWERED, IT TOOK A MONTH FOR THE DEPRESSION AND SUICIDAL THOUGHTS TO RESOLVE. THE ISSUES WITH THE VOICE WERE ONGOING, AND THEY HAVE NEVER RESOLVED SINCE THE PUMP WAS IMPLANTED. ADDITIONAL INFORMATION WAS REQUESTED TO DETERMINE WHAT DIAGNOSTICS WERE PERFORMED IN RELATION TO THE HIGH-PITCHED VOICE; WHAT ACTIONS OR INTERVENTIONS WERE TAKEN TO RESOLVE THE HIGH-PITCHED VOICE; AND IF THE HIGH-PITCHED VOICE HAD BEEN RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64259 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L