BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2133549 · Received June 15, 2011

    Report

    Report Number
    3004209178-2011-04471
    Event Type
    Injury
    Date Received
    June 15, 2011
    Report Date
    May 22, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A DRUG OVERDOSE WAS REPORTED. THE PT WAS FOUND UNRESPONSIVE IN THE CAR. THE ATTENDING PHYSICIAN IN THE EMERGENCY ROOM REPORTED ALTERED MENTAL STATUS, UNRESPONSIVENESS, RASH AND BILATERAL LOWER LIMB EDEMA. THE PT WAS TOO UNSTABLE TO BE TRANSFERRED TO THE HOSPITAL WHERE SHE IS USUALLY SEEN. THE DRUG IN THE PUMP WAS PRIALT (ZICONITIDE), DOSE AND CONCENTRATION UNK. EITHER STOPPING THE PUMP OR EMPTYING THE PUMP WAS BEING CONSIDERED. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R CATHETER: MODEL 8709SC, LOT # N274694006| EXPLANTED:| IMPLANTED: