BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1960944 · Received January 11, 2011

    Report

    Report Number
    3004209178-2011-00249
    Event Type
    Injury
    Date Received
    January 11, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 4, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED A POSSIBLE INFECTION NEAR THE PUMP REFILL PORT AREA. PER THE REPORTER, IT WAS UNK IF A CULTURE WOULD BE OBTAINED. THE PATIENT HAD CANCER AND WAS "NOT DOING WELL OVERALL." THE PUMP CONTAINED HYDROMORPHONE (DILAUDID) AND BUPIVACAINE (MARCAINE). ADD'L INFO 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 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other CATHETER: MODEL 8709SC, LOT# 263485006| EXPLANTED:| IMPLANTED: