BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2081337 · Received April 21, 2011

    Report

    Report Number
    3004209178-2011-02995
    Event Type
    Injury
    Date Received
    April 21, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 7, 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
    MN, US
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A VOLUME DISCREPANCY WAS REPORTED. THE ACTUAL RESIDUAL VOLUME WAS GREATER THAN THE EXPECTED RESIDUAL VOLUME. THE HCP HAD ASPIRATED 19ML OUT OF THE PUMP AT THE REFILL SESSION. THE MEDIATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS NOT REPORTED. ADD'L INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    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 67 YR Male Required Intervention CATHETER: MODEL 8709SC, LOT# N274840013.| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 8835, LOT# NPG020819N.| EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N274840013| IMPLANTED:| PROGRAMMER: MODEL 8835, LOT# NPG020819N| EXPLANTED:| IMPLANTED: