BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1924851 · Received December 9, 2010

    Report

    Report Number
    3004209178-2010-10352
    Event Type
    Injury
    Date Received
    December 9, 2010
    Date of Event
    December 4, 2010
    Report Date
    December 4, 2010
    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
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT STATED THAT HER BELLY WAS SWOLLEN AND SHE THOUGHT THAT THE PUMP WAS LEAKING. THE PT HAD BEEN IN AND OUT OF THE HOSPITAL OVER THE LAST WEEK. SHE STATED THAT SHE HAD "FEVERS AND EVERYONE WANTS TO KNOW WHY MY PUMP STICKS OUT SO MUCH." THE PUMP WAS INTERROGATED AND UNSPECIFIED ADVERSE EVENTS HAD OCCURRED ACCORDING TO THE PUMP LOGS AND SETTINGS. THE PT WAS DUE FOR A REFILL ON (B)(6) 2010. THE PT WAS IN A REHABILITATION CENTER AT THE TIME OF THIS REPORT. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYS WAS NOT REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization IMPLANTED:| EXPLANTED:| CATHETER: MODEL 8711, LOT# J11418R53