BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1800905 · Received August 10, 2010

    Report

    Report Number
    3004209178-2010-05998
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 10, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT HAD AN OVERDOSE WITH SYMPTOMS OF SOMNOLENCE, SEDATION AND NON-RESPONSIVENESS. PATIENT WAS ADMITTED TO THE HOSPITAL AND IN ICU ON A NARCAN DRIP, WHICH IMPROVED SYMPTOMS. PER REPORTER, IT WAS BELIEVED THAT THE CONDITION WAS NOT RELATED TO THE PUMP BUT TO THE PATIENT'S INABILITY TO METABOLIZE THE DRUG. ADDITIONAL INFORMATION HAS BEEN REQUESTED, 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 63 YR Hospitalization CATHETER: MODEL 8709SC, LOT# N196569030| IMPLANTED:| EXPLANTED: