BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3202964 · Received July 2, 2013

    Report

    Report Number
    3007566237-2013-01100
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    March 27, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: 2005-(B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ¿A COUPLE YEARS BACK, SHE HAD ¿ ACCIDENTALLY OVERDOSED FROM A DOCTOR THAT HAD PUT THE WRONG ¿ DOSAGE IN¿. IT WAS ALSO REPORTED THAT THE PATIENT WAS "VERY CONFUSED FOR A COUPLE OF HOURS AFTERWARDS". THE DEVICE SYSTEM WAS USED TO DELIVER BACLOFEN. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302927 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Other