BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2161950 · Received June 30, 2011

    Report

    Report Number
    3007566237-2011-04987
    Event Type
    Injury
    Date Received
    June 30, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 8, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN OVERDOSE WAS REPORTED WITH THE SYMPTOMS OF SLEEPINESS, UNAROUSABLE, PINPOINT PUPILS. THESE SYMPTOMS WERE NOTED A COUPLE OF DAY AGO FROM THE REPORTED DATE OF EVENT. THE PT WAS GIVEN NARCAN AND HIS SYMPTOMS IMPROVED. THE PUMP WAS STOPPED. THERE WAS NO ALARM AND PUMP PROGRAMMING WAS REPORTED AS CORRECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention CATHETER: MODEL 8709, LOT# J53426R34| IMPLANTED:| EXPLANTED: