BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1940376 · Received December 20, 2010

    Report

    Report Number
    3004209178-2010-10588
    Event Type
    Injury
    Date Received
    December 20, 2010
    Date of Event
    December 8, 2010
    Report Date
    December 8, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT EXPERIENCED AN OVERDOSE AND WAS IN A "NARCOTIC COMA." THE PT WAS HOSPITALIZED. IT WAS UNK BY THE REPORTER IF A PUMP REFILL WAS DONE. THE PUMP DELIVERED DILAUDID. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE HCP (HEALTHCARE PROFESSIONAL), 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 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| O CATHETER: MODEL 8596, LOT #: N095906005| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| ACCESSORY: MODEL 8590-1, LOT #: N103508