BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 5310908 · Received December 18, 2015

    Report

    Report Number
    3007566237-2015-03933
    Event Type
    Injury
    Date Received
    December 18, 2015
    Report Date
    November 25, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT RECEIVING INTRATHECAL BACLOFEN (TYPE, LOT NUMBER, CONCENTRATION, AND DOSE UNKNOWN) VIA AN IMPLANTED PUMP. THE PUMP'S INDICATION FOR USE (IFU) WAS LISTED AS INTRACTABLE SPASTICITY. THE PATIENT'S PUMP MALFUNCTIONED IN THE PAST AND OVERDOSED THE PATIENT. WHEN THE EVENT OCCURRED, WHAT THE ISSUE WITH THE PUMP WAS AND THE CAUSE OF THE MALFUNCTION, DRUG INFORMATION, DEVICE INFORMATION, OTHER MEDICATIONS THE PATIENT WAS TAKING AT THE TIME OF THE EVENT, MEDICAL HISTORY, TROUBLESHOOTING PERFORMED WITH RESULTS, ACTIONS/INTERVENTIONS TAKEN, AND PATIENT OUTCOME WERE NOT REPORTED. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT. A HEALTHCARE PROFESSIONAL LATER REPORTED ADDITIONAL INFORMATION. STARTING (B)(6) 2015 THE PATIENT'S PUMP WAS USED TO DELIVER GABLOFEN (LOT 2163-112; 2000 MCG/ML AT 300 MCG/DAY). THE PATIENT'S CONCOMITANT MEDICATIONS INCLUDED AVONEX, LYRICA, ATENOL, AND HCTZ. AND THE PATIENT'S MEDICAL HISTORY INCLUDED MULTIPLE SCLEROSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837476 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other